<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01700205</url>
  </required_header>
  <id_info>
    <org_study_id>HD072307</org_study_id>
    <nct_id>NCT01700205</nct_id>
  </id_info>
  <brief_title>Effect of Infant Formula on Energy Balance</brief_title>
  <acronym>GRO</acronym>
  <official_title>Impact of Diet Composition on Energy Balance and Satiety During Infancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Monell Chemical Senses Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Delaware</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Hospital of Philadelphia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Monell Chemical Senses Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overarching goal of the research we propose here is to conduct a randomized clinical&#xD;
      trial to specify the physiologic and behavioral mechanisms by which infant-formula&#xD;
      composition affects all aspects of energy balance and growth during the first years of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized clinical trial of infants whose parents decided to formula feed them;&#xD;
      mother-infant dyads will be randomized when infant is 2 weeks of age to one of 2 groups. The&#xD;
      groups will differ in the composition of the formula fed to the infant during the first year&#xD;
      of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2, 2012</start_date>
  <completion_date type="Actual">September 21, 2016</completion_date>
  <primary_completion_date type="Actual">March 17, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Between- and within-subject longitudinal trial</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Growth, Weight for Length (WLZ) Z Scores</measure>
    <time_frame>0.5 to 12.5 months with followup visit at 18.5 mos</time_frame>
    <description>At each visit, infants were weighed and measured to monitor normal growth. These anthropometric data were converted to weight-for-length (WLZ) Zscores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Growth, Weight for Age (WAZ) Z Score</measure>
    <time_frame>0.5 to 12.5 months with followup visit at 18.5 mos</time_frame>
    <description>At each visit, infants were weighed to monitor normal growth. These anthropometric data were converted to Weight for age Z (WAZ) Z scores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Growth: Length for Age (LAZ) Z Scores</measure>
    <time_frame>0.5 to 12.5 months with followup visit at 18.5 mos</time_frame>
    <description>At each visit, infants were measured to monitor normal growth. These anthropometric data were converted to Length for age Z (LAZ) Z scores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Energy Balance: Energy Intake From Infant Formula and Other Sources</measure>
    <time_frame>0.75, 3.5, 12.5 mos</time_frame>
    <description>Energy intake (kcal/day) of infant formula and other sources was determined by three-day weighed bottle intake and records of the infants' intake of any liquid or food other than formula during the three days</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Energy Balance: Sleeping Energy Expenditure (SEE)</measure>
    <time_frame>0.75, 3.5, 12.5 mos</time_frame>
    <description>Postprandial SEE (kcal/day), a proxy for resting energy expenditure in infant, was measured for a minimum of 30 min by open-circuit, indirect calorimetry using a metabolic cart with canopy hood, in a quiet, thermal-neutral room.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Energy Balance: Total Energy Expenditure (TEE)</measure>
    <time_frame>0.75, 3.5, 12.5 mos</time_frame>
    <description>TEE (kcal/day) was measured over 7 days at each of the three time points (0.75, 3.5 and12.5 mos) using the doubly labeled water method</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Energy Balance: Energy Loss in Stools</measure>
    <time_frame>0.75, 3.5, 12.5 mos</time_frame>
    <description>Stool EL (kcal/day) was determined from 3-day stool collection by bomb calorimetry at each timepoint</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feeding Behaviors, Maternal Perceptions</measure>
    <time_frame>0.5 months</time_frame>
    <description>Maternal perception of infant feeding behavior, using standardized questionnaires (Infant feeding style questionnaire; IFSQ); values ranged from 1 to 5; higher scores reflect more of that feeding style. Only baseline data reported herein.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">113</enrollment>
  <condition>Development</condition>
  <arm_group>
    <arm_group_label>Type of Formula: CMF</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Infants are randomized to feed standard cow milk formula during first year of life</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Type of Formula: EHF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infants are randomized to feed extensively hydrolyzed infant formula during first year of life</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Type of Formula</intervention_name>
    <description>infant formula</description>
    <arm_group_label>Type of Formula: CMF</arm_group_label>
    <arm_group_label>Type of Formula: EHF</arm_group_label>
    <other_name>cow milk formula (CMF)</other_name>
    <other_name>protein hydrolysate formula (EHF)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. A healthy, term (≥37 and ≤42 week gestation at birth), singleton infant.&#xD;
&#xD;
          2. Birth weight between 2500 - 4500 grams.&#xD;
&#xD;
          3. At the time of enrollment, infant must be ≤14 days old (Date of birth=day 0).&#xD;
&#xD;
          4. Mother must be 18 years or older.&#xD;
&#xD;
          5. Infant must be consuming a standard cow's milk protein infant formula and have been&#xD;
             receiving a standard cow's milk protein infant formula for at least the past 2 days&#xD;
             prior to enrollment.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Mother had gestational diabetes during pregnancy&#xD;
&#xD;
          2. Infant has condition requiring infant feedings other than feeding cow milk formula&#xD;
             from a bottle.&#xD;
&#xD;
          3. Infant has major congenital malformations (i.e. cleft palate, hemangiomas, extremity&#xD;
             malformation).&#xD;
&#xD;
          4. Infant has suspected or documented systemic or congenital infections (e.g., human&#xD;
             immunodeficiency virus, cytomegalovirus).&#xD;
&#xD;
          5. Infant has evidence of significant cardiac, respiratory, endocrinologic, hematologic,&#xD;
             gastrointestinal, or other systemic diseases. For example, infant must not be&#xD;
             receiving insulin or growth hormone.&#xD;
&#xD;
          6. Dyad be the relative (son, daughter, niece, nephew, cousin, aunt, uncle, sibling) of&#xD;
             ancillary personnel connected with the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Week</minimum_age>
    <maximum_age>3 Weeks</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julie A Mennella, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Monell Chemical Senses Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jillian Trabulsi, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Delaware</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Monell Chemical Senses Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Mennella JA, Ventura AK, Beauchamp GK. Differential growth patterns among healthy infants fed protein hydrolysate or cow-milk formulas. Pediatrics. 2011 Jan;127(1):110-8. doi: 10.1542/peds.2010-1675. Epub 2010 Dec 27.</citation>
    <PMID>21187303</PMID>
  </reference>
  <reference>
    <citation>Mennella JA, Beauchamp GK. Developmental changes in the acceptance of protein hydrolysate formula. J Dev Behav Pediatr. 1996 Dec;17(6):386-91. doi: 10.1097/00004703-199612000-00003.</citation>
    <PMID>8960567</PMID>
  </reference>
  <reference>
    <citation>Mennella JA, Lukasewycz LD, Castor SM, Beauchamp GK. The timing and duration of a sensitive period in human flavor learning: a randomized trial. Am J Clin Nutr. 2011 May;93(5):1019-24. doi: 10.3945/ajcn.110.003541. Epub 2011 Feb 10.</citation>
    <PMID>21310829</PMID>
  </reference>
  <results_reference>
    <citation>Mennella JA, Inamdar L, Pressman N, Schall JI, Papas MA, Schoeller D, Stallings VA, Trabulsi JC. Type of infant formula increases early weight gain and impacts energy balance: a randomized controlled trial. Am J Clin Nutr. 2018 Nov 1;108(5):1015-1025. doi: 10.1093/ajcn/nqy188.</citation>
    <PMID>30295700</PMID>
  </results_reference>
  <results_reference>
    <citation>Mennella JA, Papas MA, Reiter AR, Stallings VA, Trabulsi JC. Early rapid weight gain among formula-fed infants: Impact of formula type and maternal feeding styles. Pediatr Obes. 2019 Jun;14(6):e12503. doi: 10.1111/ijpo.12503. Epub 2019 Jan 10.</citation>
    <PMID>30629845</PMID>
  </results_reference>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <results_first_submitted>March 18, 2019</results_first_submitted>
  <results_first_submitted_qc>August 13, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 16, 2019</results_first_posted>
  <last_update_submitted>November 20, 2019</last_update_submitted>
  <last_update_submitted_qc>November 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Monell Chemical Senses Center</investigator_affiliation>
    <investigator_full_name>Julie A. Mennella, PhD</investigator_full_name>
    <investigator_title>Member</investigator_title>
  </responsible_party>
  <keyword>Formula Feeding</keyword>
  <keyword>Mother</keyword>
  <keyword>Moms</keyword>
  <keyword>Infants</keyword>
  <keyword>Babies</keyword>
  <keyword>Baby</keyword>
  <keyword>growth</keyword>
  <keyword>energy balance</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Energy balance measures at 0.75, 3.5 and 12.5 months of age</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>From 2012 to 2015, newly parturient women whose decision not to lactate was firmly established were recruited through ads in regional newspapers, websites and hospitals in the greater Philadelphia area.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Type of Formula: CMF</title>
          <description>infant is randomized to feed standard cow milk formula during first year of life&#xD;
Type of Formula: infant formula</description>
        </group>
        <group group_id="P2">
          <title>Type of Formula: EHF</title>
          <description>infant is randomized to feed extensively hydrolyzed infant formula during first year of life&#xD;
Type of Formula: infant formula</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="59">Mother-Infant Dyads</participants>
                <participants group_id="P2" count="54">Mother-Infant Dyads</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="44">Mother-Infant Dyads</participants>
                <participants group_id="P2" count="39">Mother-Infant Dyads</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Type of Formula: CMF</title>
          <description>infant is randomized to feed standard cow milk infant formula [CMF] during first year of life&#xD;
Type of Formula: infant formula</description>
        </group>
        <group group_id="B2">
          <title>Type of Formula: EHF</title>
          <description>infant is randomized to feed extensively hydrolyzed protein infant formula [EHF] first year of life&#xD;
Type of Formula: infant formula</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="59"/>
            <count group_id="B2" value="54"/>
            <count group_id="B3" value="113"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.4" spread="0.1"/>
                    <measurement group_id="B2" value="0.4" spread="0.1"/>
                    <measurement group_id="B3" value="0.4" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="70"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>TAS2R38 genotype, A49P allele; infants</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>AA, homozygous recessive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP, heterozygous</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PP, homozygous dominant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Growth, Weight for Length (WLZ) Z Scores</title>
        <description>At each visit, infants were weighed and measured to monitor normal growth. These anthropometric data were converted to weight-for-length (WLZ) Zscores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).</description>
        <time_frame>0.5 to 12.5 months with followup visit at 18.5 mos</time_frame>
        <population>We conducted an intention-to-treat (ITT) analyses on 113 infants regardless of study withdrawal.</population>
        <group_list>
          <group group_id="O1">
            <title>Type of Formula: CMF</title>
            <description>Infant is randomized to be fed standard cow milk formula during first year of life&#xD;
Type of Formula: CMF</description>
          </group>
          <group group_id="O2">
            <title>Type of Formula: EHF</title>
            <description>Infant is randomized to be fed extensively protein hydrolyzed infant formula during first year of life&#xD;
Type of Formula: EHF</description>
          </group>
        </group_list>
        <measure>
          <title>Growth, Weight for Length (WLZ) Z Scores</title>
          <description>At each visit, infants were weighed and measured to monitor normal growth. These anthropometric data were converted to weight-for-length (WLZ) Zscores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).</description>
          <population>We conducted an intention-to-treat (ITT) analyses on 113 infants regardless of study withdrawal.</population>
          <units>Z score</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Weight for Length Z, 0.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.26" spread="0.13"/>
                    <measurement group_id="O2" value="-0.12" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight for Length Z, 0.75 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.12" spread="0.13"/>
                    <measurement group_id="O2" value="0.13" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight for Length Z, 1.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.24" spread="0.13"/>
                    <measurement group_id="O2" value="-0.17" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight for Length Z, 2.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.24" spread="0.13"/>
                    <measurement group_id="O2" value="-0.17" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight for Length Z, 3.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                    <count group_id="O2" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.22" spread="0.13"/>
                    <measurement group_id="O2" value="-0.38" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight for Length Z, 4.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.39" spread="0.13"/>
                    <measurement group_id="O2" value="-0.24" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight for Length Z, 5.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.42" spread="0.14"/>
                    <measurement group_id="O2" value="-0.36" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight for Length Z, 6.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.52" spread="0.14"/>
                    <measurement group_id="O2" value="0.18" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight for Length Z, 7.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.59" spread="0.14"/>
                    <measurement group_id="O2" value="0.20" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight for Length Z, 8.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.76" spread="0.14"/>
                    <measurement group_id="O2" value="0.29" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight for Length Z, 9.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.71" spread="0.14"/>
                    <measurement group_id="O2" value="0.40" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight for Length Z, 10.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.76" spread="0.14"/>
                    <measurement group_id="O2" value="0.46" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight for Length Z, 11.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.72" spread="0.14"/>
                    <measurement group_id="O2" value="0.51" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight for Length Z, 12.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.70" spread="0.14"/>
                    <measurement group_id="O2" value="0.52" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight for Length Z, 18.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.80" spread="0.14"/>
                    <measurement group_id="O2" value="0.68" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>A priori power analyses determined that a sample size of 94 is required to detect a difference of 0.67 with 90% power and a 5% type 1 error rate. We conducted an intention-to-treat (ITT) analyses on the 113 infants using separate generalized estimating equations that included treatment group (CMF, EHF), time (infant age), and group × time interaction for each type of Z score (0.5-12.5 mos).</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <method>Generalized Estimating Equation</method>
            <method_desc>GEE analysis conducted with group (CMF, EHF), time (infant age, 0.5-12.5 months) and their interaction.</method_desc>
            <param_type>Slope</param_type>
            <param_value>-0.018</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0363</ci_lower_limit>
            <ci_upper_limit>-0.0002</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Growth, Weight for Age (WAZ) Z Score</title>
        <description>At each visit, infants were weighed to monitor normal growth. These anthropometric data were converted to Weight for age Z (WAZ) Z scores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).</description>
        <time_frame>0.5 to 12.5 months with followup visit at 18.5 mos</time_frame>
        <population>We conducted an intention-to-treat (ITT) analyses on 113 infants regardless of study withdrawal.</population>
        <group_list>
          <group group_id="O1">
            <title>Type of Formula: CMF</title>
            <description>Infant is randomized to be fed standard cow milk formula during first year of life&#xD;
Type of Formula: CMF</description>
          </group>
          <group group_id="O2">
            <title>Type of Formula: EHF</title>
            <description>Infant is randomized to be fed extensively protein hydrolyzed infant formula during first year of life&#xD;
Type of Formula: EHF</description>
          </group>
        </group_list>
        <measure>
          <title>Growth, Weight for Age (WAZ) Z Score</title>
          <description>At each visit, infants were weighed to monitor normal growth. These anthropometric data were converted to Weight for age Z (WAZ) Z scores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).</description>
          <population>We conducted an intention-to-treat (ITT) analyses on 113 infants regardless of study withdrawal.</population>
          <units>Z score</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Weight for Age Z score, 0.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.36" spread="0.12"/>
                    <measurement group_id="O2" value="-0.25" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight for Age Z score, 0.75 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.41" spread="0.12"/>
                    <measurement group_id="O2" value="-0.28" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight for Age Z score, 1.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.38" spread="0.12"/>
                    <measurement group_id="O2" value="-0.61" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight for Age Z score, 2.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.34" spread="0.12"/>
                    <measurement group_id="O2" value="-0.66" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight for Age Z score, 3.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                    <count group_id="O2" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.14" spread="0.12"/>
                    <measurement group_id="O2" value="0.64" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight for Age Z score, 4.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="0.13"/>
                    <measurement group_id="O2" value="-0.37" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight for Age Z score, 5.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.18" spread="0.13"/>
                    <measurement group_id="O2" value="-0.20" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight for Age Z score, 6.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.29" spread="0.13"/>
                    <measurement group_id="O2" value="-0.03" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight for Age Z score, 7.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.38" spread="0.13"/>
                    <measurement group_id="O2" value="0.02" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight for Age Z score, 8.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.50" spread="0.13"/>
                    <measurement group_id="O2" value="0.08" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight for Age Z score, 9.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.51" spread="0.13"/>
                    <measurement group_id="O2" value="0.16" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight for Age Z score, 10.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.54" spread="0.13"/>
                    <measurement group_id="O2" value="0.20" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight for Age Z score, 11.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.52" spread="0.13"/>
                    <measurement group_id="O2" value="0.28" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight for Age Z score, 12.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.52" spread="0.13"/>
                    <measurement group_id="O2" value="0.32" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight for Age Z score, 18.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.56" spread="0.14"/>
                    <measurement group_id="O2" value="0.40" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Length for Age Z score, 18.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.07" spread="0.14"/>
                    <measurement group_id="O2" value="-0.22" spread="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>A priori power analyses determined that a sample size of 94 is required to detect a difference of 0.67 with 90% power and a 5% type 1 error rate. We conducted an intention-to-treat (ITT) analyses on the 113 infants using separate generalized estimating equations that included treatment group (CMF, EHF), time (infant age), and group × time interaction for each type of Z score (0.5-12.5 mos). We provide below the parameter estimates for WLZ scores only.</non_inferiority_desc>
            <p_value>0.001</p_value>
            <method>Generalized Estimating Equations</method>
            <method_desc>GEE analysis conducted on each type of Z score separately with group (CMF, EHF), time (infant age; 0.5-12.5 months) and their interaction.</method_desc>
            <param_type>Slope</param_type>
            <param_value>-0.023</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0362</ci_lower_limit>
            <ci_upper_limit>-0.0093</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Growth: Length for Age (LAZ) Z Scores</title>
        <description>At each visit, infants were measured to monitor normal growth. These anthropometric data were converted to Length for age Z (LAZ) Z scores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).</description>
        <time_frame>0.5 to 12.5 months with followup visit at 18.5 mos</time_frame>
        <population>We conducted an intention-to-treat (ITT) analyses on 113 infants regardless of study withdrawal.</population>
        <group_list>
          <group group_id="O1">
            <title>Type of Formula: CMF</title>
            <description>Infant is randomized to be fed standard cow milk formula during first year of life&#xD;
Type of Formula: CMF</description>
          </group>
          <group group_id="O2">
            <title>Type of Formula: EHF</title>
            <description>Infant is randomized to be fed extensively protein hydrolyzed infant formula during first year of life&#xD;
Type of Formula: EHF</description>
          </group>
        </group_list>
        <measure>
          <title>Growth: Length for Age (LAZ) Z Scores</title>
          <description>At each visit, infants were measured to monitor normal growth. These anthropometric data were converted to Length for age Z (LAZ) Z scores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).</description>
          <population>We conducted an intention-to-treat (ITT) analyses on 113 infants regardless of study withdrawal.</population>
          <units>Z score</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Length for Age Z score, 0.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.49" spread="0.14"/>
                    <measurement group_id="O2" value="-0.46" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Length for Age Z score, 0.75 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.56" spread="0.14"/>
                    <measurement group_id="O2" value="0.59" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Length for Age Z score, 1.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.55" spread="0.14"/>
                    <measurement group_id="O2" value="-0.48" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Length for Age Z score, 2.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.57" spread="0.14"/>
                    <measurement group_id="O2" value="-0.62" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Length for Age Z score, 3.5mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                    <count group_id="O2" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.36" spread="0.14"/>
                    <measurement group_id="O2" value="-0.43" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Length for Age Z score, 4.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.26" spread="0.14"/>
                    <measurement group_id="O2" value="-0.21" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Length for Age Z score, 5.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.13" spread="0.14"/>
                    <measurement group_id="O2" value="-0.17" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Length for Age Z score, 6.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.05" spread="0.14"/>
                    <measurement group_id="O2" value="-0.17" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Length for Age Z score, 7.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.14"/>
                    <measurement group_id="O2" value="-0.11" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Length for Age Z score, 8.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.14"/>
                    <measurement group_id="O2" value="-0.16" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Length for Age Z score, 9.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.14"/>
                    <measurement group_id="O2" value="-0.19" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Length for Age Z score, 10.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.14"/>
                    <measurement group_id="O2" value="-0.21" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Length for Age Z score, 11.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.14"/>
                    <measurement group_id="O2" value="-0.18" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Length for Age Z score, 12.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" spread="0.14"/>
                    <measurement group_id="O2" value="-0.13" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Length for Age Z score, 18.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.07" spread="0.14"/>
                    <measurement group_id="O2" value="-0.22" spread="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>A priori power analyses determined that a sample size of 94 is required to detect a difference of 0.67 with 90% power and a 5% type 1 error rate. We conducted an intention-to-treat (ITT) analyses on the 113 infants using separate generalized estimating equations that included treatment group (CMF, EHF), time (infant age), and group × time interaction for each type of Z score (0.5-12.5 mos).</non_inferiority_desc>
            <p_value>0.32</p_value>
            <method>Generalized Estimating Equation</method>
            <method_desc>GEE analysis conducted with group (CMF, EHF), time (infant age, 0.5-12.5 months) and their interaction</method_desc>
            <param_type>Slope</param_type>
            <param_value>-0.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.058</ci_lower_limit>
            <ci_upper_limit>0.019</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Energy Balance: Energy Intake From Infant Formula and Other Sources</title>
        <description>Energy intake (kcal/day) of infant formula and other sources was determined by three-day weighed bottle intake and records of the infants' intake of any liquid or food other than formula during the three days</description>
        <time_frame>0.75, 3.5, 12.5 mos</time_frame>
        <population>Intent-to-treat analysis (N=113).</population>
        <group_list>
          <group group_id="O1">
            <title>Type of Formula: CMF</title>
            <description>Infant is randomized to be fed standard cow milk formula during first year of life&#xD;
Type of Formula: CMF</description>
          </group>
          <group group_id="O2">
            <title>Type of Formula: EHF</title>
            <description>Infant is randomized to be fed extensively protein hydrolyzed infant formula during first year of life&#xD;
Type of Formula: EHF</description>
          </group>
        </group_list>
        <measure>
          <title>Energy Balance: Energy Intake From Infant Formula and Other Sources</title>
          <description>Energy intake (kcal/day) of infant formula and other sources was determined by three-day weighed bottle intake and records of the infants' intake of any liquid or food other than formula during the three days</description>
          <population>Intent-to-treat analysis (N=113).</population>
          <units>kcal per day</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Energy Intake from Formula, 0.75 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="466" spread="14"/>
                    <measurement group_id="O2" value="383" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Energy Intake from Other Sources, 0.75 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Energy Intake from Formula, 3.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="628" spread="21"/>
                    <measurement group_id="O2" value="596" spread="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Energy Intake from Other Sources, 3.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11" spread="5"/>
                    <measurement group_id="O2" value="10" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Energy Intake from Formula, 12.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="425" spread="50"/>
                    <measurement group_id="O2" value="284" spread="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Energy Intake from Other Sources, 12.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="712" spread="51"/>
                    <measurement group_id="O2" value="863" spread="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>ANOVAs were conducted with group (CMF, EHF) as the between-subjects factor.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>ANOVA with group (CMF, EHF) as between-subjects factor were conducted on intent-to-treat sample</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <method>Repeated Measures ANOVA</method>
            <method_desc>We conducted a ANOVA with group (CMF, EHF) as between-subject factor.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Energy Balance: Sleeping Energy Expenditure (SEE)</title>
        <description>Postprandial SEE (kcal/day), a proxy for resting energy expenditure in infant, was measured for a minimum of 30 min by open-circuit, indirect calorimetry using a metabolic cart with canopy hood, in a quiet, thermal-neutral room.</description>
        <time_frame>0.75, 3.5, 12.5 mos</time_frame>
        <population>Intent-to-treat analysis (N=113).</population>
        <group_list>
          <group group_id="O1">
            <title>Type of Formula: CMF</title>
            <description>Infant is randomized to be fed standard cow milk formula during first year of life&#xD;
Type of Formula: CMF</description>
          </group>
          <group group_id="O2">
            <title>Type of Formula: EHF</title>
            <description>Infant is randomized to be fed extensively protein hydrolyzed infant formula during first year of life&#xD;
Type of Formula: EHF</description>
          </group>
        </group_list>
        <measure>
          <title>Energy Balance: Sleeping Energy Expenditure (SEE)</title>
          <description>Postprandial SEE (kcal/day), a proxy for resting energy expenditure in infant, was measured for a minimum of 30 min by open-circuit, indirect calorimetry using a metabolic cart with canopy hood, in a quiet, thermal-neutral room.</description>
          <population>Intent-to-treat analysis (N=113).</population>
          <units>kcal per day</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sleeping Energy Expenditure (0.75 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="206" spread="6"/>
                    <measurement group_id="O2" value="201" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sleeping Energy Expenditure, 3.5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="329" spread="8"/>
                    <measurement group_id="O2" value="321" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sleeping Energy Expenditure, 12.5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="507" spread="11"/>
                    <measurement group_id="O2" value="509" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>ANOVA was conducted with group (CMF, EHF) as between-subjects factor on the intent-to-treat sample.</non_inferiority_desc>
            <p_value>0.72</p_value>
            <method>Repeated Measure ANOVA</method>
            <method_desc>ANOVA was conducted with group (CMF, EHF) as between-subjects factor on the intent-to-treat sample.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Energy Balance: Total Energy Expenditure (TEE)</title>
        <description>TEE (kcal/day) was measured over 7 days at each of the three time points (0.75, 3.5 and12.5 mos) using the doubly labeled water method</description>
        <time_frame>0.75, 3.5, 12.5 mos</time_frame>
        <population>Intent-to-treat analysis (N=113).</population>
        <group_list>
          <group group_id="O1">
            <title>Type of Formula: CMF</title>
            <description>Infant is randomized to be fed standard cow milk formula during first year of life&#xD;
Type of Formula: CMF</description>
          </group>
          <group group_id="O2">
            <title>Type of Formula: EHF</title>
            <description>Infant is randomized to be fed extensively protein hydrolyzed infant formula during first year of life&#xD;
Type of Formula: EHF</description>
          </group>
        </group_list>
        <measure>
          <title>Energy Balance: Total Energy Expenditure (TEE)</title>
          <description>TEE (kcal/day) was measured over 7 days at each of the three time points (0.75, 3.5 and12.5 mos) using the doubly labeled water method</description>
          <population>Intent-to-treat analysis (N=113).</population>
          <units>kcal per day</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total energy expenditure, 0.75 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="283" spread="18"/>
                    <measurement group_id="O2" value="243" spread="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total energy expenditure, 3.5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="488" spread="24"/>
                    <measurement group_id="O2" value="444" spread="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total energy expenditure, 12.5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="859" spread="42"/>
                    <measurement group_id="O2" value="858" spread="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample</non_inferiority_desc>
            <p_value>0.72</p_value>
            <method>Repeated Measure ANOVA</method>
            <method_desc>Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Energy Balance: Energy Loss in Stools</title>
        <description>Stool EL (kcal/day) was determined from 3-day stool collection by bomb calorimetry at each timepoint</description>
        <time_frame>0.75, 3.5, 12.5 mos</time_frame>
        <population>Intent-to-treat analysis (N=113).</population>
        <group_list>
          <group group_id="O1">
            <title>Type of Formula: CMF</title>
            <description>Infant is randomized to be fed standard cow milk formula during first year of life&#xD;
Type of Formula: CMF</description>
          </group>
          <group group_id="O2">
            <title>Type of Formula: EHF</title>
            <description>Infant is randomized to be fed extensively protein hydrolyzed infant formula during first year of life&#xD;
Type of Formula: EHF</description>
          </group>
        </group_list>
        <measure>
          <title>Energy Balance: Energy Loss in Stools</title>
          <description>Stool EL (kcal/day) was determined from 3-day stool collection by bomb calorimetry at each timepoint</description>
          <population>Intent-to-treat analysis (N=113).</population>
          <units>kcal per day</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Energy Loss in Stools, 0.75 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                    <count group_id="O2" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.3" spread="3.9"/>
                    <measurement group_id="O2" value="34.9" spread="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Energy Loss in Stools, 3.5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.7" spread="1.8"/>
                    <measurement group_id="O2" value="17.0" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Energy Loss in Stools, 12.5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.1" spread="3.2"/>
                    <measurement group_id="O2" value="33.8" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample</non_inferiority_desc>
            <p_value>0.02</p_value>
            <method>Repeated Measure ANOVA</method>
            <method_desc>Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Feeding Behaviors, Maternal Perceptions</title>
        <description>Maternal perception of infant feeding behavior, using standardized questionnaires (Infant feeding style questionnaire; IFSQ); values ranged from 1 to 5; higher scores reflect more of that feeding style. Only baseline data reported herein.</description>
        <time_frame>0.5 months</time_frame>
        <population>Some mothers responded N/A on questions related to restrictive feeding styles and thus score for this subscale could not be computed.</population>
        <group_list>
          <group group_id="O1">
            <title>Type of Formula: CMF</title>
            <description>Infant is randomized to be fed standard cow milk formula during first year of life&#xD;
Type of Formula: CMF</description>
          </group>
          <group group_id="O2">
            <title>Type of Formula: EHF</title>
            <description>Infant is randomized to be fed extensively protein hydrolyzed infant formula during first year of life&#xD;
Type of Formula: EHF</description>
          </group>
        </group_list>
        <measure>
          <title>Feeding Behaviors, Maternal Perceptions</title>
          <description>Maternal perception of infant feeding behavior, using standardized questionnaires (Infant feeding style questionnaire; IFSQ); values ranged from 1 to 5; higher scores reflect more of that feeding style. Only baseline data reported herein.</description>
          <population>Some mothers responded N/A on questions related to restrictive feeding styles and thus score for this subscale could not be computed.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Laissez-Faire Feeding Style, 0.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="0.1"/>
                    <measurement group_id="O2" value="3.0" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Restrictive Feeding Style, 0.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" spread="0.1"/>
                    <measurement group_id="O2" value="2.6" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pressure to Eat Feeding Style, 0.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="0.1"/>
                    <measurement group_id="O2" value="2.4" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Responsive Feeding Styly, 0.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" spread="0.1"/>
                    <measurement group_id="O2" value="4.0" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Type of Formula: CMF</title>
          <description>infant is randomized to feed standard cow milk formula during first year of life&#xD;
Type of Formula: infant formula</description>
        </group>
        <group group_id="E2">
          <title>Type of Formula: EHF</title>
          <description>infant is randomized to feed extensively hydrolyzed infant formula during first year of life&#xD;
Type of Formula: infant formula</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Julia A. Mennella, PhD</name_or_title>
      <organization>Monell Chemical Senses Center</organization>
      <phone>267-519-4880</phone>
      <email>mennella@monell.org</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01700205
org study id: HD072307
nct id: NCT01700205
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overarching goal of the research we propose here is to conduct a randomized clinical
      trial to specify the physiologic and behavioral mechanisms by which infant-formula
      composition affects all aspects of energy balance and growth during the first years of life.
This is a randomized clinical trial of infants whose parents decided to formula feed them;
      mother-infant dyads will be randomized when infant is 2 weeks of age to one of 2 groups. The
      groups will differ in the composition of the formula fed to the infant during the first year
      of life.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Between- and within-subject longitudinal trial
primary purpose: Other
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Growth, Weight for Length (WLZ) Z Scores
time frame: 0.5 to 12.5 months with followup visit at 18.5 mos
description: At each visit, infants were weighed and measured to monitor normal growth. These anthropometric data were converted to weight-for-length (WLZ) Zscores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).
measure: Growth, Weight for Age (WAZ) Z Score
time frame: 0.5 to 12.5 months with followup visit at 18.5 mos
description: At each visit, infants were weighed to monitor normal growth. These anthropometric data were converted to Weight for age Z (WAZ) Z scores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).
measure: Growth: Length for Age (LAZ) Z Scores
time frame: 0.5 to 12.5 months with followup visit at 18.5 mos
description: At each visit, infants were measured to monitor normal growth. These anthropometric data were converted to Length for age Z (LAZ) Z scores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).
measure: Energy Balance: Energy Intake From Infant Formula and Other Sources
time frame: 0.75, 3.5, 12.5 mos
description: Energy intake (kcal/day) of infant formula and other sources was determined by three-day weighed bottle intake and records of the infants' intake of any liquid or food other than formula during the three days
measure: Energy Balance: Sleeping Energy Expenditure (SEE)
time frame: 0.75, 3.5, 12.5 mos
description: Postprandial SEE (kcal/day), a proxy for resting energy expenditure in infant, was measured for a minimum of 30 min by open-circuit, indirect calorimetry using a metabolic cart with canopy hood, in a quiet, thermal-neutral room.
measure: Energy Balance: Total Energy Expenditure (TEE)
time frame: 0.75, 3.5, 12.5 mos
description: TEE (kcal/day) was measured over 7 days at each of the three time points (0.75, 3.5 and12.5 mos) using the doubly labeled water method
measure: Energy Balance: Energy Loss in Stools
time frame: 0.75, 3.5, 12.5 mos
description: Stool EL (kcal/day) was determined from 3-day stool collection by bomb calorimetry at each timepoint
measure: Feeding Behaviors, Maternal Perceptions
time frame: 0.5 months
description: Maternal perception of infant feeding behavior, using standardized questionnaires (Infant feeding style questionnaire; IFSQ); values ranged from 1 to 5; higher scores reflect more of that feeding style. Only baseline data reported herein.
arm group label: Type of Formula: CMF
arm group type: Active Comparator
description: Infants are randomized to feed standard cow milk formula during first year of life
arm group label: Type of Formula: EHF
arm group type: Experimental
description: Infants are randomized to feed extensively hydrolyzed infant formula during first year of life
intervention type: Other
intervention name: Type of Formula
description: infant formula
arm group label: Type of Formula: CMF
arm group label: Type of Formula: EHF
other name: cow milk formula (CMF)
other name: protein hydrolysate formula (EHF)
criteria: 
gender: All
minimum age: 1 Week
maximum age: 3 Weeks
healthy volunteers: Accepts Healthy Volunteers
last name: Julie A Mennella, PhD
role: Principal Investigator
affiliation: Monell Chemical Senses Center
last name: Jillian Trabulsi, PhD
role: Principal Investigator
affiliation: University of Delaware
facility: 
country: United States
citation: Mennella JA, Ventura AK, Beauchamp GK. Differential growth patterns among healthy infants fed protein hydrolysate or cow-milk formulas. Pediatrics. 2011 Jan;127(1):110-8. doi: 10.1542/peds.2010-1675. Epub 2010 Dec 27.
PMID: 21187303
citation: Mennella JA, Beauchamp GK. Developmental changes in the acceptance of protein hydrolysate formula. J Dev Behav Pediatr. 1996 Dec;17(6):386-91. doi: 10.1097/00004703-199612000-00003.
PMID: 8960567
citation: Mennella JA, Lukasewycz LD, Castor SM, Beauchamp GK. The timing and duration of a sensitive period in human flavor learning: a randomized trial. Am J Clin Nutr. 2011 May;93(5):1019-24. doi: 10.3945/ajcn.110.003541. Epub 2011 Feb 10.
PMID: 21310829
citation: Mennella JA, Inamdar L, Pressman N, Schall JI, Papas MA, Schoeller D, Stallings VA, Trabulsi JC. Type of infant formula increases early weight gain and impacts energy balance: a randomized controlled trial. Am J Clin Nutr. 2018 Nov 1;108(5):1015-1025. doi: 10.1093/ajcn/nqy188.
PMID: 30295700
citation: Mennella JA, Papas MA, Reiter AR, Stallings VA, Trabulsi JC. Early rapid weight gain among formula-fed infants: Impact of formula type and maternal feeding styles. Pediatr Obes. 2019 Jun;14(6):e12503. doi: 10.1111/ijpo.12503. Epub 2019 Jan 10.
PMID: 30629845
responsible party type: Principal Investigator
investigator affiliation: Monell Chemical Senses Center
investigator full name: Julie A. Mennella, PhD
investigator title: Member
sharing ipd: No
ipd description: Energy balance measures at 0.75, 3.5 and 12.5 months of age
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 