<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/NCT03276884</url>
  </required_header>
  <id_info>
    <org_study_id>AL23</org_study_id>
    <nct_id>NCT03276884</nct_id>
  </id_info>
  <brief_title>Growth and Tolerance of Young Infants</brief_title>
  <official_title>Growth and Tolerance of Young Infants Fed Amino Acid-Based Formulas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Nutrition</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Nutrition</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>
      To compare growth and tolerance of healthy term infants fed two amino acid-based infant&#xD;
      formulas.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 11, 2017</start_date>
  <completion_date type="Actual">November 8, 2018</completion_date>
  <primary_completion_date type="Actual">November 8, 2018</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>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight Gain</measure>
    <time_frame>Study Day 14 to Study Day 119</time_frame>
    <description>Infant scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>GI tolerance</measure>
    <time_frame>Study Day 1 to Study Day 119</time_frame>
    <description>Parent completed questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length</measure>
    <time_frame>Study Day 1 to Study Day 119</time_frame>
    <description>Length board</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Head Circumference</measure>
    <time_frame>Study Day 1 to Study Day 119</time_frame>
    <description>Measure tape</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>Study Day 1 to Study Day 119</time_frame>
    <description>Infant scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">267</enrollment>
  <condition>Growth</condition>
  <arm_group>
    <arm_group_label>Experimental Infant Formula</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infant formula powder to be fed ad libitum</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Infant Formula</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Infant formula powder to be fed ad libitum</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Experimental Infant Formula</intervention_name>
    <description>amino acid-based infant formula powder</description>
    <arm_group_label>Experimental Infant Formula</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control Infant Formula</intervention_name>
    <description>amino acid-based infant formula powder</description>
    <arm_group_label>Control Infant Formula</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is judged to be in good health.&#xD;
&#xD;
          -  Singleton from a full-term birth with a gestational age of 37 - 42 weeks.&#xD;
&#xD;
          -  Birth weight was ≥ 2490 g (~5 lbs. 8 oz.).&#xD;
&#xD;
          -  Subject is between 0 and 8 days of age at enrollment.&#xD;
&#xD;
          -  Parent(s) confirm their intention to feed their infant the study product as the sole&#xD;
             source of nutrition for the duration of the study.&#xD;
&#xD;
          -  Parent(s) confirm their intention not to administer vitamin or mineral supplements&#xD;
             (with the exception of Vitamin D-containing supplements), solid foods or juices to&#xD;
             their infant from enrollment through the duration of the study.&#xD;
&#xD;
          -  Subject's parent(s) has voluntarily signed and dated an ICF prior to any participation&#xD;
             in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  An adverse maternal, fetal or subject medical history that is thought by the&#xD;
             investigator to have potential for effects on tolerance, growth, and/or development.&#xD;
&#xD;
          -  Subject is taking and plans to continue medications, home remedies, herbal&#xD;
             preparations, prebiotics, probiotics or rehydration fluids that might affect&#xD;
             gastrointestinal (GI) tolerance.&#xD;
&#xD;
          -  Subject participates in another study that has not been approved as a concomitant&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>8 Days</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan Kajzer, MS, RD, LD</last_name>
    <role>Study Chair</role>
    <affiliation>Abbott Nutrition</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alabama Clinical Therapeutics, LLC</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeastern Pediatric Associates</name>
      <address>
        <city>Dothan</city>
        <state>Alabama</state>
        <zip>36305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Watching Over Mothers and Babies</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Children's Clinic of Jonesboro, P.A.</name>
      <address>
        <city>Jonesboro</city>
        <state>Arkansas</state>
        <zip>72401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norwich Pediatric Group, PC</name>
      <address>
        <city>Norwich</city>
        <state>Connecticut</state>
        <zip>06360</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Research, LLC</name>
      <address>
        <city>Lake Mary</city>
        <state>Florida</state>
        <zip>32746</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Score Physician Alliance, LLC</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saltzer Medical Group</name>
      <address>
        <city>Nampa</city>
        <state>Idaho</state>
        <zip>83686</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deaconess Clinic, Inc.</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Springs Medical Research</name>
      <address>
        <city>Owensboro</city>
        <state>Kentucky</state>
        <zip>42303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Clinic of Lincoln, PC</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Associates of Fairfield, Inc.</name>
      <address>
        <city>Fairfield</city>
        <state>Ohio</state>
        <zip>45014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Clinical Research, LLC</name>
      <address>
        <city>Mentor</city>
        <state>Ohio</state>
        <zip>44060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cleveland Pediatric Research Center, LLC</name>
      <address>
        <city>Middleburg Heights</city>
        <state>Ohio</state>
        <zip>44130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Research South</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Pediatric Research 3002</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Pediatric Associates 3004</name>
      <address>
        <city>Mount Pleasant</city>
        <state>South Carolina</state>
        <zip>29464</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Pediatric Research 3003</name>
      <address>
        <city>North Charleston</city>
        <state>South Carolina</state>
        <zip>29406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memphis &amp; Shelby County Pediatric Group</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38116</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vilo Research Group Inc</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwest Children's Research Associates, PA</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tanner Clinic</name>
      <address>
        <city>Layton</city>
        <state>Utah</state>
        <zip>84041</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>November 30, 2018</last_update_submitted>
  <last_update_submitted_qc>November 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03276884
org study id: AL23
nct id: NCT03276884
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To compare growth and tolerance of healthy term infants fed two amino acid-based infant
      formulas.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Care Provider, Investigator)
measure: Weight Gain
time frame: Study Day 14 to Study Day 119
description: Infant scale
measure: GI tolerance
time frame: Study Day 1 to Study Day 119
description: Parent completed questionnaires
measure: Length
time frame: Study Day 1 to Study Day 119
description: Length board
measure: Head Circumference
time frame: Study Day 1 to Study Day 119
description: Measure tape
measure: Weight
time frame: Study Day 1 to Study Day 119
description: Infant scale
arm group label: Experimental Infant Formula
arm group type: Experimental
description: Infant formula powder to be fed ad libitum
arm group label: Control Infant Formula
arm group type: Active Comparator
description: Infant formula powder to be fed ad libitum
intervention type: Other
intervention name: Experimental Infant Formula
description: amino acid-based infant formula powder
arm group label: Experimental Infant Formula
intervention type: Other
intervention name: Control Infant Formula
description: amino acid-based infant formula powder
arm group label: Control Infant Formula
criteria: 
gender: All
minimum age: N/A
maximum age: 8 Days
healthy volunteers: Accepts Healthy Volunteers
last name: Jan Kajzer, MS, RD, LD
role: Study Chair
affiliation: Abbott Nutrition
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country: United States
responsible party type: Sponsor
sharing ipd: Undecided