Growth and Tolerance of a Partially Hydrolyzed Infant Formula

Study Overview
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Brief Summary
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The purpose of this research study is to compare the growth and tolerance of infants who consume either an infant formula with intact proteins or an infant formula with partially hydrolyzed proteins through approximately 12 months of age.

Official Title
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Growth and Tolerance of a Partially Hydrolyzed Cow's Milk Protein (PHP) Infant Formula

Conditions
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Growth

Intervention / Treatment
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* Other: Cow's milk protein infant formula
* Other: Partially hydrolyzed protein infant formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 10 to 14 days of age at randomization singleton birth Gestational age of 37 to 42 weeks Birth weight of 2500 g (5lbs 8oz or more) Exclusively receiving infant formula for at least 24 hours prior to randomization Parent or legal guardian has full intention to exclusively feed study formula through 120 days of age Parent or legal guardian agrees not to enroll infant in another interventional clinical study while participating in this study Signed informed consent and authorization to use and disclose Protected Health information Exclusion Criteria: History of underlying metabolic or chronic disease Evidence of feeding difficulties or history of formula intolerance Weight at Visit 1 is <98% of birth weight Infant was born large for gestational age from a mother who was diabetic at childbirth Infant is immunocompromised

Ages Eligible for Study
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Minimum Age: 10 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: A routine cow's milk-based infant formula<br>A routine cow's milk-based infant formula | Other: Cow's milk protein infant formula<br>* A routine cow's milk-based infant formula<br>|
| Experimental: A partially hydrolyzed cow's milk protein (PHP) infant formula<br>A partially hydrolyzed cow's milk protein (PHP) infant formula | Other: Partially hydrolyzed protein infant formula<br>* A partially hydrolyzed cow's milk protein (PHP) infant formula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of body weight gain |  | up to 120 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body length |  | up to 365 days of age | 
| Head circumference |  | up to 365 days of age | 
| Growth Z scores | weight-for-age | up to 365 days of age | 
| Growth Z scores | length-for-age | up to 365 days of age | 
| Growth Z scores | head circumference-for-age | up to 365 days of age | 
| Recall of study formula intake measured at each study visit | questionnaire | up to 365 days of age | 
| Recall of stool characteristics measured at each study visit | questionnaire | up to 365 days of age | 
| Pediatric Quality of Life Family Impact Module | questionnaire | up to 365 days of age | 
| Pediatric Quality of Life Inventory Infant Scales | Questionnaire. A 5-point response scale is utilized (0 = never a problem; 4 = always a problem). Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher scores indicate better functioning (less negative impact). | 120, 180, 275, and 365 days of age | 
| Medically confirmed adverse events collected throughout the study period |  | up to 365 days of age | 
| Specific medically confirmed adverse events related to gastrointestinal |  | up to 365 days of age | 
| Specific medically confirmed adverse events related to allergy |  | up to 365 days of age | 
| Body weight |  | up to 365 days of age |