Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants

ByHeart27 sites in 1 country311 target enrollmentDecember 10, 2019

ConditionsInfants Newborn

Overview

Phase: N/A
Intervention: Not specified
Conditions: Infants
Sponsor: ByHeart
Enrollment: 311
Locations: 27
Primary Endpoint: Weight Gain Velocity
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to demonstrate that a new infant formula for term infants supports age-appropriate growth. This study is designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations, 21CFR106.96. In this randomized, controlled trial (RCT), healthy, term, formula-fed (FF) infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants (CF) or the study formula for term infants (SF) for 16 weeks. A reference group of human milk-fed infants will also be enrolled. The primary efficacy objective is to compare the growth of infants randomized to the study infant formula (SF) versus growth of infants randomized to the standard commercial infant formula (CF).

Registry

clinicaltrials.gov

Start Date

December 10, 2019

End Date

June 11, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

ByHeart

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Term (no less than 37 weeks, 0 days and less than 42 weeks, 0 days), singleton infant.
•Birth weight of greater than or equal to 2500 grams.
•Designated healthy by a physician.
•Less than or equal to 14 days of age at enrollment.
•If formula fed, exclusively consuming and tolerating a cow's milk infant formula at enrollment and have a parent who agrees to feed the study formula as a sole source of nutrition for a minimum of 16 weeks.
•If human milk fed, predominantly consuming and tolerating human milk and have a mother/parent who plans to predominantly feed human milk as sole source of nutrition for a minimum of 16 weeks.
•Weight for age greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
•Length for age greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
•Head circumference for age greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
•Weight for length greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.

Exclusion Criteria

•Evidence of any anatomic or physiologic condition that would interfere with normal growth, development, or feeding.
•Infants required to take medications know to influence growth and development.
•Maternal history with known adverse effects on the fetus and/or the newborn infants.
•Family history of cow milk protein allergy or soy intolerance/allergy.
•Infants receiving any amount supplemental human milk with infant formula or visa-versa at time of enrollment.
•Infants from a multiple birth.

Outcomes

Primary Outcomes

Weight Gain Velocity

Time Frame: 0 - 16 weeks

G/D

Secondary Outcomes

Weight for age Z-scores(0 - 16 weeks)
72-hr record of formula intake at each study visit(0 - 16 weeks)
Human milk composition (concentrations of proteins, lipids, carbohydrates, vitamins, and minerals(3 weeks, 7 weeks)
Medically-diagnosed adverse events collected throughout the study period(0 through 16 weeks)
Parent report of infant stool frequency at each study visit(0 - 16 weeks)
Stool metabolome(2 weeks, 16 weeks)
Weight Measures(0 - 16 weeks)
Head Circumference Measures(0 - 16 weeks)
Length for age Z-scores(0 - 16 weeks)
Blood concentrations of Interleukin-6 (pg/mL), Interleukin-10 (pg/mL), and tumor necrosis factor-alpha (pg/mL)(16 weeks)
Blood concentrations of amino acids (umol/L)(16 weeks)
Head circumference for age Z-scores(0 - 16 weeks)
Length Measures(0 - 16 weeks)
Weight for length Z-scores(0 - 16 weeks)
Length Gain Velocity(0 - 16 weeks)
Parent rating of infant stool consistency at each study visit(0 - 16 weeks)
Parent report of infant disposition (fussiness, crying, gas, spit up, Infant Characteristics Questionnaire) at each study visit(0 - 16 weeks)
Stool microbiome(2 weeks, 16 weeks)