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

Completed · Not applicable

Conditions studied: Healthy, Term Infants

In brief

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.

Key facts

Study ID

NCT04389606

Run by

ByHeart

People needed

311

Starts

2020-05-12

Expected to finish

2021-06-11

Last updated by the study team

2021-07-21

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

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"

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.