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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 Oct 19, 2026, 7:19 AM 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 12, 2020 (Actual)
Primary completion
Jun 11, 2021 (Actual)
Completion
Jun 11, 2021 (Actual)
Last update posted
Jul 21, 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 21, 2021 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04389606 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →