Infant Formula and Toddler Drink Feeding Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the growth and development outcomes of infants 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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Growth

Intervention / Treatment
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* Other: Control Infant Formula
* Other: Control Toddler Drink
* Other: Experimental Infant Formula
* Other: Experimental Toddler Drink
* Other: Human Milk
* Other: Human Milk Supplemental Formula
* Other: Human Milk Toddler Drink


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 by parent report Participant's birth weight was ≥ 2490 g ( 5 lbs. 8 oz.) Parent(s) confirm their intention to feed their infant the study product as the sole source of feeding from Study Visit 1 to 6 months of age, and as the sole milk beverage during the first 12 months of life Parent(s) confirm their intention to feed the infant the assigned toddler drink from 12 months of life to 24 months of life as the primary milk beverage Parent(s) confirm their intention not to administer vitamin or mineral supplements,(except for vitamin D supplements if instructed by their healthcare professional) from enrollment through the duration of the study Parent(s) confirm their intention not to administer solid foods or juices to the infant from enrollment through 6 months of age unless recommended by the participant's HCP 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 If parent(s) elect to feed the participant human milk, they confirm that their infant was fed human milk since birth and confirm their intention to exclusively feed human milk as the sole source of feeding through 6 months of age. If parent(s) of human milk fed participant elect to supplement or wean, they confirm their intention to use the experimental supplemental/weaning formula and experimental toddler drink as the primary milk beverage. 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 Awareness of a positive drug screen (including but not limited to cocaine, heroin, or methamphetamine) in the mother or participant Suspected maternal substance abuse including alcohol Participant is taking and plans to continue medications (including over the counter (OTC), such as Mylicon® for gas), home remedies (such as juice for constipation), 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 by AN Participant has been treated with antibiotics (except for topical antibiotics, eye drops) prior to enrollment Participant has been treated with other medications (besides antibiotics) that in the opinion of the PI may affect growth, GI tolerance and/or development, prior to enrollment

Ages Eligible for Study
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Minimum Age: 0 Days
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>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>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 Reference Group<br>Human Milk | Other: Human Milk<br>* Ad libitum or as instructed by HCP<br>Other: Human Milk Supplemental Formula<br>* Ad libitum if consuming supplemented formula; feeding period up to 12 months of age<br>Other: Human Milk Toddler Drink<br>*  16 fl oz per day if providing supplemental nutrition other than HM; feeding period from 12 to 24 months of age<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth | weight for age z-score | Study Day 1 to 6 Months of Age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of respiratory infection between study groups | Adverse event reports | Study Day 1 to 24 Months of Age | 
| Number of respiratory infection episodes between study groups | Adverse event reports | Study Day 1 to 24 Months of Age | 
| Incidence of infection morbidity between study groups | Adverse event reports | Study Day 1 to 24 Months of Age | 
| Number of episodes of infection morbidity between study groups | Adverse event reports | Study Day 1 to 24 Months of Age | 
| Weight | Interval weight gain per day | Study Day 1 to 24 Months of Age | 
| Length | Interval length gain per day | Study Day 1 to 24 Months of Age | 
| Head Circumference | Interval head circumference gain per day | Study Day 1 to 24 Months of Age | 
| Gastrointestinal Tolerance | Parent completed diary | Study Day 1 to 12 months of Age |