Growth and Tolerance of Young Infants

Completed · Not applicable

Conditions studied: Growth

In brief

To compare growth and tolerance of healthy term infants fed two amino acid-based infant formulas.

Key facts

Study ID

NCT03276884

Run by

Abbott Nutrition

People needed

267

Starts

2017-10-11

Expected to finish

2018-11-08

Last updated by the study team

2018-12-03

Who can join

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

You may qualify if…

• Subject is judged to be in good health.
• Singleton from a full-term birth with a gestational age of 37 - 42 weeks.
• Birth weight was ≥ 2490 g (\~5 lbs. 8 oz.).
• Subject is between 0 and 8 days of age at enrollment.
• Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.
• Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D-containing supplements), solid foods or juices to their infant from enrollment through the duration of the study.
• Subject's parent(s) has voluntarily signed and dated an ICF prior to any participation in the study.

You may not qualify if…

• An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
• Subject is taking and plans to continue medications, home remedies, herbal preparations, prebiotics, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance.
• Subject participates in another study that has not been approved as a concomitant study.

Where it is running

• Alabama Clinical Therapeutics, LLC — Birmingham, Alabama, United States
• Southeastern Pediatric Associates — Dothan, Alabama, United States
• Watching Over Mothers and Babies — Tucson, Arizona, United States
• The Children's Clinic of Jonesboro, P.A. — Jonesboro, Arkansas, United States
• Norwich Pediatric Group, PC — Norwich, Connecticut, United States
• Children's Research, LLC — Lake Mary, Florida, United States
• Score Physician Alliance, LLC — St. Petersburg, Florida, United States
• Saltzer Medical Group — Nampa, Idaho, United States
• Deaconess Clinic, Inc. — Evansville, Indiana, United States
• Springs Medical Research — Owensboro, Kentucky, United States
• Women's Clinic of Lincoln, PC — Lincoln, Nebraska, United States
• Pediatric Associates of Fairfield, Inc. — Fairfield, Ohio, United States
• Institute of Clinical Research, LLC — Mentor, Ohio, United States
• The Cleveland Pediatric Research Center, LLC — Middleburg Heights, Ohio, United States
• Medical Research South — Charleston, South Carolina, United States
• Coastal Pediatric Research 3002 — Charleston, South Carolina, United States
• Coastal Pediatric Associates 3004 — Mt. Pleasant, South Carolina, United States
• Coastal Pediatric Research 3003 — North Charleston, South Carolina, United States
• Memphis & Shelby County Pediatric Group — Memphis, Tennessee, United States
• Vilo Research Group Inc — Houston, Texas, United States
• Southwest Children's Research Associates, PA — San Antonio, Texas, United States
• Tanner Clinic — Layton, Utah, United States

Full record on ClinicalTrials.gov

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