Follow-up Study of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants
1 other identifier
interventional
311
1 country
27
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started May 2020
Typical duration for not_applicable healthy
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2020
CompletedStudy Start
First participant enrolled
May 12, 2020
CompletedFirst Posted
Study publicly available on registry
May 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 11, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 11, 2021
CompletedJuly 21, 2021
July 1, 2021
1.1 years
May 12, 2020
July 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight Gain Velocity
G/D
up to 24 weeks
Secondary Outcomes (18)
Weight Measures
20 weeks, 24 weeks
Length Measures
20 weeks, 24 weeks
Length Gain Velocity
20 weeks, 24 weeks
Head Circumference Measures
20 weeks, 24 weeks
Weight for age Z-scores
20 weeks, 24 weeks
- +13 more secondary outcomes
Study Arms (3)
Study Formula (SF)
EXPERIMENTALNew infant formula for term infants
Comparator Formula (CF)
ACTIVE COMPARATORCommercially available infant formula for term infants
Human Milk Reference Group
NO INTERVENTIONHuman milk
Interventions
New infant formula for term infants fed ad lib
Commercially available infant formula for term infants fed ad lib
Eligibility Criteria
You may qualify if:
- 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"
You may not qualify if:
- 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"
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ByHeartlead
- Paidion Research, Inc.collaborator
Study Sites (27)
Alabama Clinical Therapeutics
Birmingham, Alabama, 35126, United States
Watching Over Mothers and Babies
Tucson, Arizona, 85712, United States
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, 72401, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, 72212, United States
San Gabriel Women's Health
Arcadia, California, 91007, United States
Northern California Research
Sacramento, California, 95812, United States
Optum
Colorado Springs, Colorado, 80922, United States
Topaz Clinical Research
Apopka, Florida, 32703, United States
Sarkis Clinical Trials
Gainesville, Florida, 32607, United States
Avanza Medical Research
Pensacola, Florida, 32503, United States
PAS-Research
Tampa, Florida, 33613, United States
Clinical Research Prime
Idaho Falls, Idaho, 83404, United States
Southern Clinical Research
Zachary, Louisiana, 70791, United States
Sierra Clinical Research
Las Vegas, Nevada, 89106, United States
Pediatric Associates of Mt. Carmel, Inc
Cincinnati, Ohio, 45245, United States
Schear Family Practice
Dayton, Ohio, 45406, United States
Pediatric Associates of Fairfield, Inc.
Fairfield, Ohio, 45014, United States
Institute of Clinical Research
Mentor, Ohio, 44060, United States
Coastal Pediatric Research
Charleston, South Carolina, 29414, United States
Coastal Pediatric Associates
Summerville, South Carolina, 29486, United States
HMG Primary Care at Sapling Grove
Bristol, Tennessee, 37620, United States
Jackson Clinic North
Jackson, Tennessee, 38305, United States
HMG Pediatrics at Kingsport
Kingsport, Tennessee, 37660, United States
Houston Clinical Research Associates
Houston, Texas, 77090, United States
DCOL Center for Clinical Research
Longview, Texas, 75165, United States
ACRC Trials Plano Pediatrics
Plano, Texas, 75093, United States
Tanner Clinic
Layton, Utah, 84041, United States
Related Publications (1)
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.
PMID: 35666855DERIVED
Study Officials
- STUDY DIRECTOR
Devon Kuehn, MD
ByHeart, Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2020
First Posted
May 15, 2020
Study Start
May 12, 2020
Primary Completion
June 11, 2021
Study Completion
June 11, 2021
Last Updated
July 21, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share