Infants Fed Extensively Hydrolyzed Casein-Based Infant Formulas

Infant Development Clinical Trial

Official title:

Growth and Tolerance of Infants Fed Extensively Hydrolyzed Casein-Based Infant Formulas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04006236
• Other study ID #: AL33
• Status: Completed
• Phase: N/A
• Start date: August 5, 2019
• Est. completion date: September 20, 2021

Study information

• Verified date: September 2021
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: September 20, 2021
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 14 Days

Eligibility

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

Related Conditions & MeSH terms

• Infant Development

Intervention

Other:
• Experimental Infant Formula
Feed Ad Libitum
• Control Infant Formula
Feed Ad Libitum

Locations

Country	Name	City	State
United States	MedPharmics, LLC	Albuquerque	New Mexico
United States	Paramount Research Solutions	College Park	Georgia
United States	Pediatric Associates of Fairfield, Inc.	Fairfield	Ohio
United States	Ventavia Research Group, Llc	Fort Worth	Texas
United States	MedPharmics, LLC	Gulfport	Mississippi
United States	Ventavia Research Group	Houston	Texas
United States	Midsouth Center for Clinical Research	Memphis	Tennessee
United States	Institute of Clinical Research, LLC	Mentor	Ohio
United States	MedPharmics, LLC	Metairie	Louisiana
United States	The Cleveland Pediatric Research Center, LLC	Middleburg Heights	Ohio
United States	Quality Clinical Research Inc	Omaha	Nebraska
United States	Springs Medical Research	Owensboro	Kentucky
United States	MedPharmics, LLC	Phoenix	Arizona
United States	Ventavia Research Group, LLC	Plano	Texas
United States	Children's Hospital	Sioux Falls	South Dakota
United States	PMG Research of Peidmont Healthcare	Statesville	North Carolina
United States	Watching Over Mothers & Babies	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Infant Feeding and Stool Patterns Questionnaire	Parent completed questionnaire; 16 questions with 5 categories scaled in the negative direction	Exit or DOA 119
Other	Infant Behavior Questionnaire	Parent completed questionnaire; 22 questions with 5 categories scaled in the negative direction	Exit or DOA 119
Other	Formula Satisfaction Questionnaire	Parent completed questionnaire; 13 questions of up to 5 categories scaled in the negative direction	Exit or DOA 119
Primary	Weight	Interval weight gain per day	Day of Age (DOA) 14 to 119
Secondary	Length	Interval length gain per day	Study Day (SD) 1 to DOA 119
Secondary	Head Circumference	Interval HC gain per day	Study Day (SD) 1 to DOA 119
Secondary	Stool Characteristics	Parent Completed Diary	Study Day (SD) 1 to DOA 119
Secondary	Formula Intake	Parent Completed Diary	Study Day (SD) 1 to DOA 119