Follow-up Study of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants

The purpose of this two-month follow-up study is to continue to follow growth, safety, and other health outcomes of infants fed a new infant formula for term infants or comparator formula. A reference group of human milk-fed infants will also be followed. This study is designed in accordance with Good Clinical Practice guidelines.

Study Overview

• Status: Completed
• Conditions: Healthy; Term 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: 3 months to 4 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects who enrolled and completed the previous phase of the clinical trial: NCT04218929 "Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants"

Exclusion Criteria:

• Subjects who did not enroll in the previous phase of the clinical trial: NCT04218929 "Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants"

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; Other: Comparator Formula (CF); Commercially available infant formula for term infants fed ad lib
Active Comparator: Comparator Formula (CF); Commercially available infant formula for term infants	Other: Study Formula (SF); New infant formula for term infants fed ad lib; 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	up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Measures	KG	20 weeks, 24 weeks
Length Measures	CM	20 weeks, 24 weeks
Length Gain Velocity	CM/D	20 weeks, 24 weeks
Head Circumference Measures	CM	20 weeks, 24 weeks
Weight for age Z-scores	Weight for age Z-scores compared to World Health Organization (WHO) growth standards	20 weeks, 24 weeks
Length for age Z-scores	Length for age Z-scores compared to WHO growth standards	20 weeks, 24 weeks
Head circumference for age Z-scores	Head circumference for age Z-scores compared to WHO growth standards	20 weeks, 24 weeks
Weight for length Z-scores	Weight for length Z-scores compared to WHO growth standards	20 weeks, 24 weeks
72-hr record of formula intake at each study visit	oz/d	20 weeks, 24 weeks
Blood concentrations of Interleukin-6 (pg/mL), Interleukin-10 (pg/mL), and tumor necrosis factor-alpha (pg/mL)	Concentration	24 weeks
Blood concentrations of amino acids (umol/L)	Concentration	24 weeks
Human milk composition (concentrations of proteins, lipids, carbohydrates, vitamins, and minerals	Concentration	24 weeks
Medically-diagnosed adverse events collected throughout the study period	Frequency	16-24 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]).	20 weeks, 24 weeks
Parent report of infant stool frequency at each study visit	Mean	20 weeks, 24 weeks
Parent report of infant disposition (fussiness, crying, gas, spit up, Infant Characteristics Questionnaire) at each study visit	Mean	20 weeks, 24 weeks
Stool microbiome	Fecal microbial taxa and community abundance	24 weeks
Stool metabolome	Targeted and Untargeted Metabolomics	24 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): May 12, 2020
• Primary Completion (Actual): June 11, 2021
• Study Completion (Actual): June 11, 2021

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 15, 2020

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

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

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