Infant Formula and Toddler Drink Feeding Intervention

Study Overview
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Brief Summary
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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.

Official Title
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Infant Formula and Toddler Drink Feeding Intervention Through 24 Months of Age

Conditions
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Respiratory Infections in Children

Intervention / Treatment
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* Other: Control Infant Formula
* Other: Control Toddler Drink
* Other: Experimental Infant Formula
* Other: Experimental Toddler Drink
* Other: Supplemental Formula for HM Group
* Other: Toddler Drink for HM group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is judged to be in good health as determined from participant's medical history Participant is a singleton from a full-term birth with a gestational age of 37 - 42 weeks Participant's birth weight was ≥ 2490 g ( 5 lbs. 8 oz.) If parent(s) elect to formula feed the participant they confirm their intention to feed their participant the study product as the sole source of feeding until 4 months of age, and as the sole milk beverage during the first 12 months of life If parent(s) elect to formula feed the participant, they confirm their intention to feed the participant the assigned toddler drink from 12 months of life to 24 months of life as the primary milk beverage If parent(s) elect to feed the participant mother's human milk, they confirm that their infant was exclusively fed mother's human milk since birth and confirm their intention to continue exclusively feeding human milk as the sole source of feeding through 4 months of age If parent(s) of human milk fed participant elect to supplement or wean after 4 months to 24 months of age, they confirm their intention to use the supplemental/weaning formula or toddler drink as the primary milk beverage Parent(s) of formula-fed participant confirm their intention not to administer vitamin or mineral supplements, from enrollment through the duration of the study Parent(s) confirm their intention not to administer solid foods or juices to the participant from enrollment through 6 months of age Participant's parent(s) has voluntarily signed and dated an informed consent form (ICF), approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study. Exclusion Criteria: An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development Participant is taking and plans to continue medications (including over the counter (OTC), home remedies, herbal preparations, prebiotics or probiotics, or rehydration fluids that might affect GI tolerance Participant is in another study that has not been approved as a concomitant study Participant has been treated with antibiotics prior to enrollment

Ages Eligible for Study
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Maximum Age: 14 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Feeding Group<br>Ready to feed milk-based product | Other: Control Infant Formula<br>* Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age<br>Other: Control Toddler Drink<br>* 16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age<br>|
| Experimental: Experimental Feeding Group<br>Ready to feed milk-based product with oligosaccharides | Other: Experimental Infant Formula<br>* Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age<br>Other: Experimental Toddler Drink<br>* 16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age<br>|
| Other: Human Milk (HM) Reference Group<br>HM from infant's own mother and as needed supplemental infant formula and toddler milk-based product | Other: Supplemental Formula for HM Group<br>* Ad libitum formula given up to 12 months of age if HM is supplemented<br>Other: Toddler Drink for HM group<br>* 16 fl oz per day if weaned from HM feedings<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of respiratory infection between study groups | Adverse event reports | Study Day 1 to 6 Months of Age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection morbidity between study groups | Adverse event reports | Study Day 1 to 24 Months of Age |