Clinical trialNCT04389606CompletedInterventional

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

SponsorByHeartEnrollment311HealthyTerm Infants

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Devon Kuehn, MD
ByHeart, Inc.
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

27 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Alabama Clinical Therapeutics
Birmingham, Alabama, United States
Watching Over Mothers and Babies
Tucson, Arizona, United States
the Children'S Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, United States
San Gabriel Women'S Health
Arcadia, California, United States
Northern California Research
Sacramento, California, United States
Optum
Colorado Springs, Colorado, United States
Topaz Clinical Research
Apopka, Florida, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
Avanza Medical Research
Pensacola, Florida, United States
Pas-Research
Tampa, Florida, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
Southern Clinical Research
Zachary, Louisiana, United States
Sierra Clinical Research
Las Vegas, Nevada, United States
Pediatric Associates of Mt. Carmel, Inc
Cincinnati, Ohio, United States
Schear Family Practice
Dayton, Ohio, United States
Pediatric Associates of Fairfield, Inc.
Fairfield, Ohio, United States
Institute of Clinical Research
Mentor, Ohio, United States
Coastal Pediatric Research
Charleston, South Carolina, United States
Coastal Pediatric Associates
Summerville, South Carolina, United States
Hmg Primary Care at Sapling Grove
Bristol, Tennessee, United States
Jackson Clinic North
Jackson, Tennessee, United States
Hmg Pediatrics at Kingsport
Kingsport, Tennessee, United States
Houston Clinical Research Associates
Houston, Texas, United States
Dcol Center for Clinical Research
Longview, Texas, United States
Acrc Trials Plano Pediatrics
Plano, Texas, United States
Tanner Clinic
Layton, Utah, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 12 May 2020
Primary completion: 11 Jun 2021
Completion: 11 Jun 2021
Last update posted: 21 Jul 2021
Registered enrollment: 311
Registry id: NCT04389606

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.