Growth and Safety Clinical Trial on a New Infant Formula.

Study Overview
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Brief Summary
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The aim of the study is to assess age-appropriate growth of healthy infants fed a new organic milk-based infant formula.

Detailed Description
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A 16-weeks length, randomized, controlled, double-blind, parallel study designed to evaluate growth and tolerance of healthy infants fed milk-based infant formula. The study has been designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations 21 CFR 106.96

Official Title
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Evaluation of Growth and Safety of Healthy Term Infants Consuming an Organic Formula.

Conditions
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Healthy Growth

Intervention / Treatment
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* Other: Control Infant Formula
* Other: Organic Infant Formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy gestational term (≥ 37 wks; ≤ 41 wks and 6 days). Birth weight of ≥ 2,500 g and ≤ 4,500 g. Postnatal age ≤ 14 days. Singleton. Designated as healthy, that is no recognized diseases. Weight, length, weight-for-length, and head circumference within ≥ 5th and ≤ 95th percentile for age-sex according to World Health Organization (WHO) growth standards (birth to 24 months). Exclusive feeding and tolerating cow milk formula at time of enrollment. Parent(s) or legal guardians are willing and able to feed the assigned formula as sole source of nutrition. Parent(s) or legal guardians are willing and able to participate in anthropometric procedures. Parent(s) or legal guardians have voluntarily signed and dated required participation forms, such as the ICF approved by an IRB. Exclusion Criteria: An infant from a multiple birth, such as twin, triplet, or the like. Personal or immediate family history of cow-milk protein allergy or intolerance. Currently on any medication to treat growth failure or that may significantly impact growth. Evidence of any anatomic and/or physiologic condition that would interfere with normal growth, development, or feeding, such as genetic, neurological, gastrointestinal, cardiac, pulmonary, hepatic, or renal. A maternal history with known adverse effects on the fetus and/or the newborn infant, such as positive HIV, insulin-dependent diabetes, opioid exposure during pregnancy. Enrolled in another clinical trial involving a drug, nutrition supplement, device, or intervention.

Ages Eligible for Study
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Minimum Age: 1 Day
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
Interventional Model Description: A controlled, decentralized, double-blind trial of healthy, term, formula-fed infants randomized to one of two infant formulas: Control Formula (a standard, commercially available infant formula) or Investigational Formula for 16 weeks.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Formula<br>A standard, milk-based, infant formula. | Other: Control Infant Formula<br>* Powder, standard commercial infant formula.<br>|
| Experimental: Investigational Formula<br>An organic milk-based infant formula. | Other: Organic Infant Formula<br>* Powder, organic milk-based infant formula.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Formula intake. | Volume of formula consumed. ml/day | Study Day 1 to Study Day 112 | 
| Weight. | Weight. Weight gain velocity. g and g/day | Study Day 1 to Study Day 112 | 
| Length. | Length. Length gain velocity. cm and cm/day. | Study Day 1 to Study Day 112 | 
| Head circumference. | Head circumference. Head circumference gain velocity. cm and cm/day | Study Day 1 to Study Day 112 | 
| Anthropometry Z-scores. | Weight for age Z-score. Length for age Z-score. Weight for length Z-score. Head circumference for age Z-score. | Study Day 1 to Study Day 112 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Formula tolerance. | Frequency of adverse events. Fussiness. Inconsolable crying. | Study Day 1 to Study Day 112 | 
| Gastrointestinal characteristic. | Stool consistency. Stools/day. Regurgitation. Gas. | Study Day 1 to Study Day 112 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant formula, cow milk, growth