Infants Fed Extensively Hydrolyzed Casein-Based Infant Formulas

Completed · Not applicable

Conditions studied: Infant Development

In brief

This is a randomized, controlled, double-blind, multicenter parallel study to evaluate the growth, tolerance and compliance of healthy infants fed infant formulas with extensively hydrolyzed casein protein.

Key facts

Study ID

NCT04006236

Run by

Abbott Nutrition

People needed

245

Starts

2019-08-05

Expected to finish

2021-09-20

Last updated by the study team

2021-09-24

Who can join

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

You may qualify if…

• Participant is judged to be in good health
• Participant is a singleton from a full-term birth with a gestational age of 37-42 weeks
• Participant's birth weight was > 2490 g (\~5 lbs. 8 oz.)
• 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 vitamins, minerals (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment throughout the duration of the study
• Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization

You may not qualify if…

• An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
• Participant is taking and plans to continue taking medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
• Participant participates in another study that has not been approved as a concomitant study by AN.
• Participant has an allergy or intolerance to any ingredient in the study product
• Participant has been treated with antibiotics within 1 week prior to enrollment

Where it is running

• MedPharmics, LLC — Phoenix, Arizona, United States
• Watching Over Mothers & Babies — Tucson, Arizona, United States
• Paramount Research Solutions — College Park, Georgia, United States
• Springs Medical Research — Owensboro, Kentucky, United States
• MedPharmics, LLC — Metairie, Louisiana, United States
• MedPharmics, LLC — Gulfport, Mississippi, United States
• Quality Clinical Research Inc — Omaha, Nebraska, United States
• MedPharmics, LLC — Albuquerque, New Mexico, United States
• PMG Research of Peidmont Healthcare — Statesville, North Carolina, 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
• Children's Hospital — Sioux Falls, South Dakota, United States
• Midsouth Center for Clinical Research — Memphis, Tennessee, United States
• Ventavia Research Group, Llc — Fort Worth, Texas, United States
• Ventavia Research Group — Houston, Texas, United States
• Ventavia Research Group, LLC — Plano, Texas, United States

Full record on ClinicalTrials.gov

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