New Infant Formula Supports Adequate Growth in Healthy Infants

Study Overview
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Brief Summary
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The objective of the present study is to evaluate the growth, safety, and tolerance in healthy, term infants consuming a new to market infant formula (Formula A) and a commercially available infant formula (Formula B) with daily weight gain as the primary outcome. As secondary outcomes, the study will evaluate other growth parameters, tolerance, and safety.

Detailed Description
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This is a controlled randomized parallel assignment, masked (Participant, Care Provider, Investigator, Outcomes Assessor) study. Healthy infants will be assigned an Investigational (Formula A) experimental new milk based infant formula, or an active comparator Control (Formula B) Enfamil (trademark brand name) marketed milk based infant formula. The period for the study is 365 days (52 weeks) using repeated-measures mixed model (RMMM). Anthropometry, formula intake, tolerance, and stool characteristics will be assessed. Medically confirmed adverse events will be recorded throughout the study.

Official Title
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New Infant Formula Supports Adequate Growth and Safety Study in Healthy Infants

Conditions
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Infant Development

Intervention / Treatment
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* Other: Formula A
* Other: Formula B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants will be eligible to participate if they meet all of the following conditions. At birth the infant must be: Only infants whose parent(s) or legal guardian(s) have decided to feed infant formula as the sole source of nutrition, will be approached for potential study enrollment Healthy, term (early term/no less than 37 weeks, 0 days through late term/no greater than 41 weeks, 6 days), singleton infant Have a birth weight of ≥ 2500 grams At the time of the baseline/enrollment visit, infants must be: Designated as healthy by a physician ≤21 days post-natal age (Date of Birth = Day 0) Weight for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts Length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts Head circumference for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts Weight for length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts Exclusively consuming and tolerating a cow's milk infant formula at time of enrollment Have parent(s) or legal guardian(s) who agree to feed the study formula to the study subject as his/her sole source of nutrition for the duration of the study Have parent(s) or legal guardian(s) who have read and voluntarily signed an Informed Consent form approved by the Institutional Review Board prior to any participation in the study. Exclusion Criteria: Infants will be ineligible if they have any of the following conditions that are judged by a physician to interfere with the infant's normal growth, development, and/or tolerance to an infant formula: Infants showing evidence of anatomic and physiologic defects of the respiratory tract, or other congenital defects (as determined by the clinician) Evidence of chronic hepatic, gastrointestinal, renal, cardiac, pulmonary, or neurological diseases Having a maternal history with known adverse effects on the fetus and/or the newborn infant, such as diabetes (gestational diabetes is acceptable if infant's birth weight is < 4300 g), active tuberculosis, perinatal infection, Having a family history of cow's milk protein intolerance/allergy Are an infant from a multiple birth (twin, triplet, etc.) Mothers who smoked cigarettes Mothers who used illicit drugs during pregnancy.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 21 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Formula feed infants will be randomized to receive either a new infant formula formulated for healthy term infants (Formula A) or a commercially available infant formula for healthy term infants (Formula B). Infants will consume the formula for a total of 52-weeks.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Formula A<br>An experimental Infant Formula, Milk-Based Powder with Iron, for healthy term infants 0 to 12 months of age. | Other: Formula A<br>* Formula A is to be feed as the sole source of nutrition for 52 weeks to healthy term infants.<br>|
| Active Comparator: Formula B<br>A Commercially available Infant Formula, for healthy term infants 0 to 12 months of age (Enfamil TM, Milk-Based Powder with Iron) | Other: Formula B<br>* Formula B is to be feed as the sole source of nutrition for 52 weeks to healthy term infants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain change measured at set intervals for first 365 days | The infants will be weighed naked while lying quietly on a calibrated electronic scale accurate to 10 grams. | 1-21 days, 42 days, 84 days, 126 days, 180 days, 270 days, 365 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability evaluated and recorded by parents in daily journal on stool observations at start through 365 days using VAS (Visual Analogue Scale) | Daily stool frequency Stool consistency (on a five-point scale: 1 = watery, 2 = soft/pudding like, 3 = soft formed, 4 = dry formed, 5 = dry/hard pellets) Constipation (0 = absent, 1 = mild, 2 = moderate, 3 = severe) Diarrhea (0 = absent, 1 = mild, 2 = moderate, 3 = severe) Colic (0 = absent, 1 = mild, 2 = moderate, 3 = severe) Vomiting (0 = absent, 1 = mild, 2 = moderate, 3 = severe) Regurgitation (0 = absent, 1 = mild, 2 = moderate, 3 = severe) Flatulence (0 = absent, 1 = mild, 2 = moderate, 3 = severe) Nappy rash (0 = absent, 1 = mild, 2 = moderate, 3 = severe) | Daily through 365 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant Formula