<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/NCT04495738</url>
  </required_header>
  <id_info>
    <org_study_id>AL38</org_study_id>
    <nct_id>NCT04495738</nct_id>
  </id_info>
  <brief_title>Infant Formula and Toddler Drink Feeding Intervention</brief_title>
  <official_title>Infant Formula and Toddler Drink Feeding Intervention Through 24 Months of Age</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>
      The purpose of this randomized, multi-center, controlled, double-blind, parallel study is to&#xD;
      evaluate the health and developmental outcomes of children fed a new infant formula and&#xD;
      toddler drink through 24 months of age.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Change in research focus&#xD;
  </why_stopped>
  <start_date type="Actual">August 10, 2020</start_date>
  <completion_date type="Actual">April 12, 2021</completion_date>
  <primary_completion_date type="Actual">April 12, 2021</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of respiratory infection between study groups</measure>
    <time_frame>Study Day 1 to 6 Months of Age</time_frame>
    <description>Adverse event reports</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Infection morbidity between study groups</measure>
    <time_frame>Study Day 1 to 24 Months of Age</time_frame>
    <description>Adverse event reports</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Weight</measure>
    <time_frame>Study Day 1 to 24 Months of Age</time_frame>
    <description>Weight in grams</description>
  </other_outcome>
  <other_outcome>
    <measure>Length</measure>
    <time_frame>Study Day 1 to 24 Months of Age</time_frame>
    <description>Length in cm</description>
  </other_outcome>
  <other_outcome>
    <measure>Head Circumference (HC)</measure>
    <time_frame>Study Day 1 to 24 Months of Age</time_frame>
    <description>HC in cm</description>
  </other_outcome>
  <other_outcome>
    <measure>Gastrointestinal Tolerance</measure>
    <time_frame>Study Day 1 to 119 Days of Age</time_frame>
    <description>Parent completed diary</description>
  </other_outcome>
  <other_outcome>
    <measure>Dietary Intake</measure>
    <time_frame>Study Day 1 to 24 Months of Age</time_frame>
    <description>Parent completed diary</description>
  </other_outcome>
  <other_outcome>
    <measure>Infant Feeding and Stool Patterns Questionnaire</measure>
    <time_frame>28 Days of Age to 119 Days of Age</time_frame>
    <description>Parent completed questionnaire; 16, 5-point Likert scale questions, scaled in the negative direction</description>
  </other_outcome>
  <other_outcome>
    <measure>Infant Behavior Questionnaire</measure>
    <time_frame>119 Days of Age</time_frame>
    <description>Parent completed questionnaire; 22 questions with 5-point Likert scale questions, scaled in the negative direction</description>
  </other_outcome>
  <other_outcome>
    <measure>Formula Satisfaction Questionnaire</measure>
    <time_frame>28 Days of Age to 6 Months of Age</time_frame>
    <description>Parent completed questionnaire; 12 questions with 5-point Likert scale questions scaled in the negative direction</description>
  </other_outcome>
  <other_outcome>
    <measure>Toddler Drink Satisfaction Questionnaire</measure>
    <time_frame>15 Months of Age to 24 Months of Age</time_frame>
    <description>Parent completed questionnaire; 12 questions with 5-point Likert scale questions scaled in the negative direction</description>
  </other_outcome>
  <other_outcome>
    <measure>Human Milk Sample</measure>
    <time_frame>84 Days of Age</time_frame>
    <description>Oligosaccharide characterization</description>
  </other_outcome>
  <other_outcome>
    <measure>Stool Sample</measure>
    <time_frame>Study Day 1 to 24 Months of Age</time_frame>
    <description>Microbiota characterization</description>
  </other_outcome>
  <other_outcome>
    <measure>Saliva Sample</measure>
    <time_frame>84 Days of Age</time_frame>
    <description>Maternal-Infant secretor status</description>
  </other_outcome>
  <other_outcome>
    <measure>Modified Home Short Form</measure>
    <time_frame>6 Months of Age to 24 Months of Age</time_frame>
    <description>Parent completed questionnaire; 8 questions related to the home environment adapted from the HSF compared between groups</description>
  </other_outcome>
  <other_outcome>
    <measure>Behavioral Questionnaire</measure>
    <time_frame>12 Months of Age to 24 Months of Age</time_frame>
    <description>Parent completed questionnaire; 8 questions related to sleep, physical activity and screen time</description>
  </other_outcome>
  <other_outcome>
    <measure>Ages &amp; Stages Questionnaire</measure>
    <time_frame>6 Months of Age to 18 Months of Age</time_frame>
    <description>Parent completed questionnaire; 5 Developmental areas; Scores to the six questions in each area are totaled; Higher scores indicate more positive outcomes</description>
  </other_outcome>
  <other_outcome>
    <measure>Bayley Scale of Infant &amp; Toddler Development</measure>
    <time_frame>12 Months of Age to 24 Months of Age</time_frame>
    <description>Examiner rated assessment; Scores are totaled and compared to normative age group data and between groups</description>
  </other_outcome>
  <other_outcome>
    <measure>MacArthur Communicative Developmental Inventory</measure>
    <time_frame>12 Months of Age to 24 Months of Age</time_frame>
    <description>Parent completed questionnaire of Words and Gestures and Words and Sentences; Percentiles compared to normative group data and between groups</description>
  </other_outcome>
  <other_outcome>
    <measure>Edinburgh Postnatal Depression Scale</measure>
    <time_frame>28 Days of Age</time_frame>
    <description>Mother completed questionnaire; Scores for each of the 10 items are totaled; Higher scores indicate more depressive symptoms</description>
  </other_outcome>
  <other_outcome>
    <measure>Medications</measure>
    <time_frame>Study Day 1 to 24 Months of Age</time_frame>
    <description>Medication usage including frequency and reason for use</description>
  </other_outcome>
  <other_outcome>
    <measure>Adverse Events</measure>
    <time_frame>Study Day 1 to 24 Months of Age</time_frame>
    <description>Standard Adverse Event reporting</description>
  </other_outcome>
  <other_outcome>
    <measure>Health Resource Utilization</measure>
    <time_frame>Study Day 1 to 24 Months of Age</time_frame>
    <description>Number of visits</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">168</enrollment>
  <condition>Respiratory Infections in Children</condition>
  <arm_group>
    <arm_group_label>Control Feeding Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ready to feed milk-based product</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental Feeding Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ready to feed milk-based product with oligosaccharides</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Human Milk (HM) Reference Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>HM from infant's own mother and as needed supplemental infant formula and toddler milk-based product</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control Infant Formula</intervention_name>
    <description>Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age</description>
    <arm_group_label>Control Feeding Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control Toddler Drink</intervention_name>
    <description>16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age</description>
    <arm_group_label>Control Feeding Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Experimental Infant Formula</intervention_name>
    <description>Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age</description>
    <arm_group_label>Experimental Feeding Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Experimental Toddler Drink</intervention_name>
    <description>16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age</description>
    <arm_group_label>Experimental Feeding Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Supplemental Formula for HM Group</intervention_name>
    <description>Ad libitum formula given up to 12 months of age if HM is supplemented</description>
    <arm_group_label>Human Milk (HM) Reference Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Toddler Drink for HM group</intervention_name>
    <description>16 fl oz per day if weaned from HM feedings</description>
    <arm_group_label>Human Milk (HM) Reference Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant is judged to be in good health as determined from participant's medical&#xD;
             history&#xD;
&#xD;
          -  Participant is a singleton from a full-term birth with a gestational age of 37 - 42&#xD;
             weeks&#xD;
&#xD;
          -  Participant's birth weight was ≥ 2490 g (~5 lbs. 8 oz.)&#xD;
&#xD;
          -  If parent(s) elect to formula feed the participant they confirm their intention to&#xD;
             feed their participant the study product as the sole source of feeding until 4 months&#xD;
             of age, and as the sole milk beverage during the first 12 months of life&#xD;
&#xD;
          -  If parent(s) elect to formula feed the participant, they confirm their intention to&#xD;
             feed the participant the assigned toddler drink from 12 months of life to 24 months of&#xD;
             life as the primary milk beverage&#xD;
&#xD;
          -  If parent(s) elect to feed the participant mother's human milk, they confirm that&#xD;
             their infant was exclusively fed mother's human milk since birth and confirm their&#xD;
             intention to continue exclusively feeding human milk as the sole source of feeding&#xD;
             through 4 months of age&#xD;
&#xD;
          -  If parent(s) of human milk fed participant elect to supplement or wean after 4 months&#xD;
             to 24 months of age, they confirm their intention to use the supplemental/weaning&#xD;
             formula or toddler drink as the primary milk beverage&#xD;
&#xD;
          -  Parent(s) of formula-fed participant confirm their intention not to administer vitamin&#xD;
             or mineral supplements, from enrollment through the duration of the study&#xD;
&#xD;
          -  Parent(s) confirm their intention not to administer solid foods or juices to the&#xD;
             participant from enrollment through 6 months of age&#xD;
&#xD;
          -  Participant's parent(s) has voluntarily signed and dated an informed consent form&#xD;
             (ICF), approved by an Institutional Review Board/Independent Ethics Committee&#xD;
             (IRB/IEC) and provided Health Insurance Portability and Accountability Act (HIPAA) (or&#xD;
             other applicable privacy regulation) authorization prior to any participation in the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  An adverse maternal, fetal or participant medical history that is thought by the&#xD;
             investigator to have potential for effects on tolerance, growth, and/or development&#xD;
&#xD;
          -  Participant is taking and plans to continue medications (including over the counter&#xD;
             (OTC), home remedies, herbal preparations, prebiotics or probiotics, or rehydration&#xD;
             fluids that might affect GI tolerance&#xD;
&#xD;
          -  Participant is in another study that has not been approved as a concomitant study&#xD;
&#xD;
          -  Participant has been treated with antibiotics prior to enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>14 Days</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bridget Barrett Reis, PhD, RD</last_name>
    <role>Study Chair</role>
    <affiliation>Abbott Nutrition</affiliation>
  </overall_official>
  <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>Eclipse Clinical Research</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85745</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>Applied Research Center of Arkansas</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72019</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boeson Research 3266</name>
      <address>
        <city>Grand Junction</city>
        <state>Colorado</state>
        <zip>81505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TOPAZ Clinical Research, Inc.</name>
      <address>
        <city>Apopka</city>
        <state>Florida</state>
        <zip>32703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASCLEPES Research Centers</name>
      <address>
        <city>Spring Hill</city>
        <state>Florida</state>
        <zip>34609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research 3259</name>
      <address>
        <city>Macon</city>
        <state>Georgia</state>
        <zip>31210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Prime</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leavitt Clinical Research</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qualmedica Research 3272</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47715</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deaconess Clinic, Inc.</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47725</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qualmedica Research, LLC 3270</name>
      <address>
        <city>Owensboro</city>
        <state>Kentucky</state>
        <zip>42301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research 3080</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boeson Research 3265</name>
      <address>
        <city>Kalispell</city>
        <state>Montana</state>
        <zip>59901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boeson Research 3267</name>
      <address>
        <city>Missoula</city>
        <state>Montana</state>
        <zip>59804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research 3264</name>
      <address>
        <city>Grand Island</city>
        <state>Nebraska</state>
        <zip>68803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research 3263</name>
      <address>
        <city>Hastings</city>
        <state>Nebraska</state>
        <zip>68901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio Pediatric Research Association</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cyn3rgy Research</name>
      <address>
        <city>Gresham</city>
        <state>Oregon</state>
        <zip>97030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holston Medical Group</name>
      <address>
        <city>Kingsport</city>
        <state>Tennessee</state>
        <zip>37660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MultiCare Institute for Research &amp; Innovation</name>
      <address>
        <city>Dickinson</city>
        <state>Texas</state>
        <zip>77539</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maximos Ob/Gyn</name>
      <address>
        <city>League City</city>
        <state>Texas</state>
        <zip>77573</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DCOL Center for Clinical Research</name>
      <address>
        <city>Longview</city>
        <state>Texas</state>
        <zip>75605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PAS Research 3273</name>
      <address>
        <city>McAllen</city>
        <state>Texas</state>
        <zip>78501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multicare Rockwood Pediatrics</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercury Clinical Research 3261</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>May 12, 2021</last_update_submitted>
  <last_update_submitted_qc>May 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Tract Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04495738
org study id: AL38
nct id: NCT04495738
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this randomized, multi-center, controlled, double-blind, parallel study is to
      evaluate the health and developmental outcomes of children fed a new infant formula and
      toddler drink through 24 months of age.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidence of respiratory infection between study groups
time frame: Study Day 1 to 6 Months of Age
description: Adverse event reports
measure: Infection morbidity between study groups
time frame: Study Day 1 to 24 Months of Age
description: Adverse event reports
measure: Weight
time frame: Study Day 1 to 24 Months of Age
description: Weight in grams
measure: Length
time frame: Study Day 1 to 24 Months of Age
description: Length in cm
measure: Head Circumference (HC)
time frame: Study Day 1 to 24 Months of Age
description: HC in cm
measure: Gastrointestinal Tolerance
time frame: Study Day 1 to 119 Days of Age
description: Parent completed diary
measure: Dietary Intake
time frame: Study Day 1 to 24 Months of Age
description: Parent completed diary
measure: Infant Feeding and Stool Patterns Questionnaire
time frame: 28 Days of Age to 119 Days of Age
description: Parent completed questionnaire; 16, 5-point Likert scale questions, scaled in the negative direction
measure: Infant Behavior Questionnaire
time frame: 119 Days of Age
description: Parent completed questionnaire; 22 questions with 5-point Likert scale questions, scaled in the negative direction
measure: Formula Satisfaction Questionnaire
time frame: 28 Days of Age to 6 Months of Age
description: Parent completed questionnaire; 12 questions with 5-point Likert scale questions scaled in the negative direction
measure: Toddler Drink Satisfaction Questionnaire
time frame: 15 Months of Age to 24 Months of Age
description: Parent completed questionnaire; 12 questions with 5-point Likert scale questions scaled in the negative direction
measure: Human Milk Sample
time frame: 84 Days of Age
description: Oligosaccharide characterization
measure: Stool Sample
time frame: Study Day 1 to 24 Months of Age
description: Microbiota characterization
measure: Saliva Sample
time frame: 84 Days of Age
description: Maternal-Infant secretor status
measure: Modified Home Short Form
time frame: 6 Months of Age to 24 Months of Age
description: Parent completed questionnaire; 8 questions related to the home environment adapted from the HSF compared between groups
measure: Behavioral Questionnaire
time frame: 12 Months of Age to 24 Months of Age
description: Parent completed questionnaire; 8 questions related to sleep, physical activity and screen time
measure: Ages & Stages Questionnaire
time frame: 6 Months of Age to 18 Months of Age
description: Parent completed questionnaire; 5 Developmental areas; Scores to the six questions in each area are totaled; Higher scores indicate more positive outcomes
measure: Bayley Scale of Infant & Toddler Development
time frame: 12 Months of Age to 24 Months of Age
description: Examiner rated assessment; Scores are totaled and compared to normative age group data and between groups
measure: MacArthur Communicative Developmental Inventory
time frame: 12 Months of Age to 24 Months of Age
description: Parent completed questionnaire of Words and Gestures and Words and Sentences; Percentiles compared to normative group data and between groups
measure: Edinburgh Postnatal Depression Scale
time frame: 28 Days of Age
description: Mother completed questionnaire; Scores for each of the 10 items are totaled; Higher scores indicate more depressive symptoms
measure: Medications
time frame: Study Day 1 to 24 Months of Age
description: Medication usage including frequency and reason for use
measure: Adverse Events
time frame: Study Day 1 to 24 Months of Age
description: Standard Adverse Event reporting
measure: Health Resource Utilization
time frame: Study Day 1 to 24 Months of Age
description: Number of visits
arm group label: Control Feeding Group
arm group type: Active Comparator
description: Ready to feed milk-based product
arm group label: Experimental Feeding Group
arm group type: Experimental
description: Ready to feed milk-based product with oligosaccharides
arm group label: Human Milk (HM) Reference Group
arm group type: Other
description: HM from infant's own mother and as needed supplemental infant formula and toddler milk-based product
intervention type: Other
intervention name: Control Infant Formula
description: Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age
arm group label: Control Feeding Group
intervention type: Other
intervention name: Control Toddler Drink
description: 16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age
arm group label: Control Feeding Group
intervention type: Other
intervention name: Experimental Infant Formula
description: Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age
arm group label: Experimental Feeding Group
intervention type: Other
intervention name: Experimental Toddler Drink
description: 16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age
arm group label: Experimental Feeding Group
intervention type: Other
intervention name: Supplemental Formula for HM Group
description: Ad libitum formula given up to 12 months of age if HM is supplemented
arm group label: Human Milk (HM) Reference Group
intervention type: Other
intervention name: Toddler Drink for HM group
description: 16 fl oz per day if weaned from HM feedings
arm group label: Human Milk (HM) Reference Group
criteria: 
gender: All
minimum age: N/A
maximum age: 14 Days
healthy volunteers: Accepts Healthy Volunteers
last name: Bridget Barrett Reis, PhD, RD
role: Study Chair
affiliation: Abbott Nutrition
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country: United States
responsible party type: Sponsor
mesh term: Respiratory Tract Infections
sharing ipd: No