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

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).

Study Overview

• Status: Completed
• Conditions: Newborn; Infants
• Intervention / Treatment: Other: Study Formula (SF); Other: Comparator Formula (CF)

• Study Type: Interventional
• Enrollment (Actual): 311
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35126
      • Alabama Clinical Therapeutics
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Watching Over Mothers and Babies
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • The Children's Clinic of Jonesboro, P.A.
    • Little Rock, Arkansas, United States, 72212
      • Applied Research Center of Arkansas
  • California
    • Arcadia, California, United States, 91007
      • San Gabriel Women's Health
    • Sacramento, California, United States, 95812
      • Northern California Research
  • Colorado
    • Colorado Springs, Colorado, United States, 80922
      • Optum
  • Florida
    • Apopka, Florida, United States, 32703
      • Topaz Clinical Research
    • Gainesville, Florida, United States, 32607
      • Sarkis Clinical Trials
    • Pensacola, Florida, United States, 32503
      • Avanza Medical Research
    • Tampa, Florida, United States, 33613
      • PAS-Research
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Clinical Research Prime
  • Louisiana
    • Zachary, Louisiana, United States, 70791
      • Southern Clinical Research
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Sierra Clinical Research
  • Ohio
    • Cincinnati, Ohio, United States, 45245
      • Pediatric Associates of Mt. Carmel, Inc
    • Dayton, Ohio, United States, 45406
      • Schear Family Practice
    • Fairfield, Ohio, United States, 45014
      • Pediatric Associates of Fairfield, Inc.
    • Mentor, Ohio, United States, 44060
      • Institute of Clinical Research
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Coastal Pediatric Research
    • Summerville, South Carolina, United States, 29486
      • Coastal Pediatric Associates
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • HMG Primary Care at Sapling Grove
    • Jackson, Tennessee, United States, 38305
      • Jackson Clinic North
    • Kingsport, Tennessee, United States, 37660
      • HMG Pediatrics at Kingsport
  • Texas
    • Houston, Texas, United States, 77090
      • Houston Clinical Research Associates
    • Longview, Texas, United States, 75165
      • DCOL Center for Clinical Research
    • Plano, Texas, United States, 75093
      • ACRC Trials Plano Pediatrics
  • Utah
    • Layton, Utah, United States, 84041
      • Tanner Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 2 weeks (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.
• Not currently receiving and have a parent/guardian who does not plan to give pre- and/or pro-biotics for the full duration of the study.
• Not currently participating in an interventional clinical trial and have a parent(s) or legal guardian(s) who agree not to enroll the infant in an interventional clinical trial while participating in this trial.
• Have parent(s) or legal guardian(s) who are capable of completing the written records, questionnaires, and study procedures required by the protocol.
• Have a parent(s) or legal guardian(s) who have read and voluntarily signed the Institutional Review Board Informed Consent prior to study participation.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Formula (SF); New infant formula for term infants	Other: Study Formula (SF); New infant formula for term infants fed ad lib
Active Comparator: Comparator Formula (CF); Commercially available infant formula for term infants	Other: Comparator Formula (CF); Commercially available infant formula for term infants fed ad lib
No Intervention: Human Milk Reference Group; Human milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Gain Velocity	G/D	0 - 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Measures	KG	0 - 16 weeks
Length Measures	CM	0 - 16 weeks
Length Gain Velocity	CM/D	0 - 16 weeks
Head Circumference Measures	CM	0 - 16 weeks
Weight for age Z-scores	Weight for age Z-scores compared to World Health Organization (WHO) growth standards	0 - 16 weeks
Length for age Z-scores	Length for age Z-scores compared to WHO growth standards	0 - 16 weeks
Head circumference for age Z-scores	Head circumference for age Z-scores compared to WHO growth standards	0 - 16 weeks
Weight for length Z-scores	Weight for length Z-scores compared to WHO growth standards	0 - 16 weeks
72-hr record of formula intake at each study visit	OZ/D	0 - 16 weeks
Blood concentrations of Interleukin-6 (pg/mL), Interleukin-10 (pg/mL), and tumor necrosis factor-alpha (pg/mL)	Concentration	16 weeks
Blood concentrations of amino acids (umol/L)	Concentration	16 weeks
Human milk composition (concentrations of proteins, lipids, carbohydrates, vitamins, and minerals	Concentration	3 weeks, 7 weeks
Medically-diagnosed adverse events collected throughout the study period	Frequency	0 through 16 weeks
Parent rating of infant stool consistency at each study visit	Mean. Quinlan et al Likert scale; 0=no bowel movement, 1=hard [dry hard pellets], 2=formed [definite shape, not dry], 3=soft [no definite shape, pasty], 4=loose [no shape, some water], 5=watery [no shape, mainly water]).	0 - 16 weeks
Parent report of infant stool frequency at each study visit	Mean	0 - 16 weeks
Parent report of infant disposition (fussiness, crying, gas, spit up, Infant Characteristics Questionnaire) at each study visit	Mean	0 - 16 weeks
Stool microbiome	Fecal microbial taxa and community abundance	2 weeks, 16 weeks
Stool metabolome	Targeted and Untargeted Metabolomics	2 weeks, 16 weeks

Collaborators and Investigators

• Sponsor: ByHeart
• Collaborators: Paidion Research, Inc.
• Investigators: Study Director: Devon Kuehn, MD, ByHeart, Inc.

Publications and helpful links

General Publications

• Kuehn D, Zeisel SH, Orenstein DF, German JB, Field CJ, Teerdhala S, Knezevic A, Patil S, Donovan SM, Lonnerdal B. Effects of a Novel High-Quality Protein Infant Formula on Energetic Efficiency and Tolerance: A Randomized Trial. J Pediatr Gastroenterol Nutr. 2022 Oct 1;75(4):521-528. doi: 10.1097/MPG.0000000000003490. Epub 2022 Jun 6.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2019
• Primary Completion (Actual): June 11, 2021
• Study Completion (Actual): June 11, 2021

Study Registration Dates

• First Submitted: December 12, 2019
• First Submitted That Met QC Criteria: January 2, 2020
• First Posted (Actual): January 6, 2020

Study Record Updates

• Last Update Posted (Actual): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 28, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Infant; Healthy Subjects; Infant Formula
• Other Study ID Numbers: SS-101-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No