Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants

Completed · Not applicable

Conditions studied: Infants, Newborn

In brief

The purpose of this study is to demonstrate that a new infant formula for term infants supports age-appropriate growth. This study is designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations, 21CFR106.96. In this randomized, controlled trial (RCT), healthy, term, formula-fed (FF) infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants (CF) or the study formula for term infants (SF) for 16 weeks. A reference group of human milk-fed infants will also be enrolled. The primary efficacy objective is to compare the growth of infants randomized to the study infant formula (SF) versus growth of infants randomized to the standard commercial infant formula (CF).

Key facts

Study ID

NCT04218929

Run by

ByHeart

People needed

311

Starts

2019-12-10

Expected to finish

2021-06-11

Last updated by the study team

2021-06-30

Who can join

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

You may qualify if…

• Term (no less than 37 weeks, 0 days and less than 42 weeks, 0 days), singleton infant.
• Birth weight of greater than or equal to 2500 grams.
• Designated healthy by a physician.
• Less than or equal to 14 days of age at enrollment.
• If formula fed, exclusively consuming and tolerating a cow's milk infant formula at enrollment and have a parent who agrees to feed the study formula as a sole source of nutrition for a minimum of 16 weeks.
• If human milk fed, predominantly consuming and tolerating human milk and have a mother/parent who plans to predominantly feed human milk as sole source of nutrition for a minimum of 16 weeks.
• Weight for age greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
• Length for age greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
• Head circumference for age greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
• Weight for length greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
• Not currently receiving and have a parent/guardian who does not plan to give pre- and/or pro-biotics for the full duration of the study.
• Not currently participating in an interventional clinical trial and have a parent(s) or legal guardian(s) who agree not to enroll the infant in an interventional clinical trial while participating in this trial.
• Have parent(s) or legal guardian(s) who are capable of completing the written records, questionnaires, and study procedures required by the protocol.
• Have a parent(s) or legal guardian(s) who have read and voluntarily signed the Institutional Review Board Informed Consent prior to study participation.

You may not qualify if…

• Evidence of any anatomic or physiologic condition that would interfere with normal growth, development, or feeding.
• Infants required to take medications know to influence growth and development.
• Maternal history with known adverse effects on the fetus and/or the newborn infants.
• Family history of cow milk protein allergy or soy intolerance/allergy.
• Infants receiving any amount supplemental human milk with infant formula or visa-versa at time of enrollment.
• Infants from a multiple birth.

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.