Infants Fed Extensively Hydrolyzed Casein-Based Infant Formulas

Not Applicable

Completed

• Conditions: Infant Development

• Registration Number: NCT04006236
• Lead Sponsor: Abbott Nutrition

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-01
• Study First Submitted QC: 2019-07-01
• Study First Posted: 2019-07-05
• Study Start: 2019-08-05
• Status Verified: 2021-09
• Primary Completion: 2021-09-20
• Study Completion: 2021-09-20
• Last Update Submitted: 2021-09-23
• Last Update Posted: 2021-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Weight	Day of Age (DOA) 14 to 119	Interval weight gain per day

Secondary Outcome Measures

Name	Time	Method
Length	Study Day (SD) 1 to DOA 119	Interval length gain per day
Formula Intake	Study Day (SD) 1 to DOA 119	Parent Completed Diary
Head Circumference	Study Day (SD) 1 to DOA 119	Interval HC gain per day
Stool Characteristics	Study Day (SD) 1 to DOA 119	Parent Completed Diary

Trial Locations

Locations (14)

MedPharmics, LLC; 🇺🇸 Albuquerque, New Mexico, 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

Quality Clinical Research Inc; 🇺🇸 Omaha, Nebraska, 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

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