Infants Fed Extensively Hydrolyzed Casein-Based Infant Formulas

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

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.

Study Overview

• Status: Completed
• Conditions: Infant Development
• Intervention / Treatment: Other: Experimental Infant Formula; Other: Control Infant Formula

• Study Type: Interventional
• Enrollment (Actual): 245
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85015
      • MedPharmics, LLC
    • Tucson, Arizona, United States, 85712
      • Watching Over Mothers & Babies
  • Georgia
    • College Park, Georgia, United States, 30349
      • Paramount Research Solutions
  • Kentucky
    • Owensboro, Kentucky, United States, 42303
      • Springs Medical Research
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • MedPharmics, LLC
  • Mississippi
    • Gulfport, Mississippi, United States, 30503
      • MedPharmics, LLC
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research Inc
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • MedPharmics, LLC
  • North Carolina
    • Statesville, North Carolina, United States, 28625
      • PMG Research of Peidmont Healthcare
  • Ohio
    • Fairfield, Ohio, United States, 45014
      • Pediatric Associates of Fairfield, Inc.
    • Mentor, Ohio, United States, 44060
      • Institute of Clinical Research, LLC
    • Middleburg Heights, Ohio, United States, 44130
      • The Cleveland Pediatric Research Center, LLC
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Children's Hospital
  • Tennessee
    • Memphis, Tennessee, United States, 38116
      • Midsouth Center for Clinical Research
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Ventavia Research Group, LLC
    • Houston, Texas, United States, 77008
      • Ventavia Research Group
    • Plano, Texas, United States, 75093
      • Ventavia Research Group, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 2 weeks (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Infant Formula; extensively hydrolyzed casein protein	Other: Experimental Infant Formula; Feed Ad Libitum
Active Comparator: Control Infant Formula; extensively hydrolyzed casein protein	Other: Control Infant Formula; Feed Ad Libitum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Interval weight gain per day	Day of Age (DOA) 14 to 119

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant Feeding and Stool Patterns Questionnaire	Parent completed questionnaire; 16 questions with 5 categories scaled in the negative direction	Exit or DOA 119
Infant Behavior Questionnaire	Parent completed questionnaire; 22 questions with 5 categories scaled in the negative direction	Exit or DOA 119
Formula Satisfaction Questionnaire	Parent completed questionnaire; 13 questions of up to 5 categories scaled in the negative direction	Exit or DOA 119

Collaborators and Investigators

• Sponsor: Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2019
• Primary Completion (Actual): September 20, 2021
• Study Completion (Actual): September 20, 2021

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 23, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: AL33

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No