Growth and Safety Clinical Trial on a New Infant Formula

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess age-appropriate growth of healthy infants fed a new infant formula. In this randomized, controlled trial, healthy, term, formula-fed infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants or the new infant formula for term infants for 16 weeks. A reference group of human milk-fed infants will also be enrolled. This study is designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations, 21CFR106.96. This study allows caregivers to participate completely from the comfort of their own home.

Official Title
-----------------
A Randomized, Controlled Trial Evaluating Growth and Safety in Infants Fed a New Infant Formula

Conditions
-----------------
Weight Gain

Intervention / Treatment
-----------------
* Other: New Infant Formula
* Other: Commercial Infant Formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal term infant (37-42 weeks gestation at birth) Infant <15 (+3) days of age at first study feeding, Birth constitutes day 0 Infant birth weight of ≥2500 g (5.5 lbs.) Healthy Infant Caregiver who has previously decided to exclusively feed infant formula or exclusively breastfeed and is willing to continue with current feeding method throughout the study (breastfeeding or formula feeding) Caregiver willing to conform to protocol requirements (e.g. measuring, feeding, completion of food intake and tolerance diaries, and reporting of AEs) Caregiver willing and able to sign informed consent Exclusion Criteria: Infant born in multiple birth (i.e., twins, triplets, etc.) Infant born with medical complications (e.g., neurological, cerebral palsy, etc.) Infant with family history (parents or siblings) of confirmed Milk or Soy allergies Infant with failure to thrive, fever, any GI tract abnormalities (e.g., short gut, gastroesophageal reflux, etc.), any congenital illness or malformation that may affect infant feeding or normal growth Caregiver intent to feed non-study formula or solid food during the study

Ages Eligible for Study
-----------------
Minimum Age: 0 Days
Maximum Age: 14 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A decentralized, randomized, controlled trial of healthy term breastfed and formula-fed infants for 16 weeks
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New Infant Formula<br>New infant formula for healthy term infants | Other: New Infant Formula<br>* New infant formula fed daily ad libitum<br>|
| Active Comparator: Commercial Infant Formula<br>Standard, commercially available infant formula for healthy term infants | Other: Commercial Infant Formula<br>* Commercially available infant formula fed daily ad libitum<br>|
| No Intervention: Human Milk<br>Breastfed infants serve as a reference group | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain from baseline to 16 weeks feeding | Weight gain g/day | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length gain from baseline to 16 weeks feeding | Length gain | 16 weeks | 
| Head Circumference gain from baseline to 16 weeks feeding | Head Circumference gain | 16 weeks | 
| Volume of formula consumed during 3-consecutive day intervals | Volume of formula consumed | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infant, formula, in-home