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Completed Not applicable Interventional Accepts healthy volunteers

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

ClinicalTrials.gov ID: NCT04389606

Public ClinicalTrials.gov record NCT04389606. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 7:32 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT04389606
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
ByHeart
Industry
Enrollment
311 participants

Conditions and interventions

Eligibility (public fields only)

Age range
16 Weeks to 19 Weeks
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 11, 2020
Primary completion
Jun 10, 2021
Completion
Jun 10, 2021
Last update posted
Jul 20, 2021

2020 – 2021

United States locations

U.S. sites
27
U.S. states
14
U.S. cities
27
Facility City State ZIP Site status
Alabama Clinical Therapeutics Birmingham Alabama 35126
Watching Over Mothers and Babies Tucson Arizona 85712
The Children's Clinic of Jonesboro, P.A. Jonesboro Arkansas 72401
Applied Research Center of Arkansas Little Rock Arkansas 72212
San Gabriel Women's Health Arcadia California 91007
Northern California Research Sacramento California 95812
Optum Colorado Springs Colorado 80922
Topaz Clinical Research Apopka Florida 32703
Sarkis Clinical Trials Gainesville Florida 32607
Avanza Medical Research Pensacola Florida 32503
PAS-Research Tampa Florida 33613
Clinical Research Prime Idaho Falls Idaho 83404
Southern Clinical Research Zachary Louisiana 70791
Sierra Clinical Research Las Vegas Nevada 89106
Pediatric Associates of Mt. Carmel, Inc Cincinnati Ohio 45245
Schear Family Practice Dayton Ohio 45406
Pediatric Associates of Fairfield, Inc. Fairfield Ohio 45014
Institute of Clinical Research Mentor Ohio 44060
Coastal Pediatric Research Charleston South Carolina 29414
Coastal Pediatric Associates Summerville South Carolina 29486
HMG Primary Care at Sapling Grove Bristol Tennessee 37620
Jackson Clinic North Jackson Tennessee 38305
HMG Pediatrics at Kingsport Kingsport Tennessee 37660
Houston Clinical Research Associates Houston Texas 77090
DCOL Center for Clinical Research Longview Texas 75165
ACRC Trials Plano Pediatrics Plano Texas 75093
Tanner Clinic Layton Utah 84041

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04389606, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 20, 2021 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04389606 live on ClinicalTrials.gov.

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