Growth and Tolerance of a Partially Hydrolyzed Infant Formula

Growth and Tolerance of a Partially Hydrolyzed Cow's Milk Protein (PHP) Infant Formula

The purpose of this research study is to compare the growth and tolerance of infants who consume either an infant formula with intact proteins or an infant formula with partially hydrolyzed proteins through approximately 12 months of age.

Study Overview

• Status: Completed
• Conditions: Growth
• Intervention / Treatment: Other: Cow's milk protein infant formula; Other: Partially hydrolyzed protein infant formula

• Study Type: Interventional
• Enrollment (Actual): 244
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nakia Goodwin; Phone Number: 812-429-5453; Email: nakia.goodwin@rb.com

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Birmingham Pediatric Associates
    • Dothan, Alabama, United States, 36305
      • Southeastern Pediatric Associates
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Visions Clinical Research-Tucson
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Northwest Arkansas Pediatric Clinic
    • Jonesboro, Arkansas, United States, 72401
      • The Children's Clinic of Jonesboro
  • Florida
    • Tampa, Florida, United States, 33613
      • Pas Research
  • Georgia
    • Union City, Georgia, United States, 30339
      • Rophe Adult & Pediatric Medicine
  • Idaho
    • Nampa, Idaho, United States, 83686
      • Saltzer Health
  • Kentucky
    • Owensboro, Kentucky, United States, 42303
      • Springs Medical Research
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • Meridian Clinical Research
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • The Jackson Clinic
  • Texas
    • Longview, Texas, United States, 75605
      • DCOL Center for Clinical Research
    • McAllen, Texas, United States, 78501
      • Pas Research

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 10 to 14 days of age at randomization
• singleton birth
• Gestational age of 37 to 42 weeks
• Birth weight of 2500 g (5lbs 8oz or more)
• Exclusively receiving infant formula for at least 24 hours prior to randomization
• Parent or legal guardian has full intention to exclusively feed study formula through 120 days of age
• Parent or legal guardian agrees not to enroll infant in another interventional clinical study while participating in this study
• Signed informed consent and authorization to use and disclose Protected Health information

Exclusion Criteria:

• History of underlying metabolic or chronic disease
• Evidence of feeding difficulties or history of formula intolerance
• Weight at Visit 1 is <98% of birth weight
• Infant was born large for gestational age from a mother who was diabetic at childbirth
• Infant is immunocompromised

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
Active Comparator: A routine cow's milk-based infant formula	Other: Cow's milk protein infant formula; A routine cow's milk-based infant formula
Experimental: A partially hydrolyzed cow's milk protein (PHP) infant formula	Other: Partially hydrolyzed protein infant formula; A partially hydrolyzed cow's milk protein (PHP) infant formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of body weight gain	up to 120 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body length		up to 365 days of age
Head circumference		up to 365 days of age
Growth Z scores	weight-for-age	up to 365 days of age
Growth Z scores	length-for-age	up to 365 days of age
Growth Z scores	head circumference-for-age	up to 365 days of age
Recall of study formula intake measured at each study visit	questionnaire	up to 365 days of age
Recall of stool characteristics measured at each study visit	questionnaire	up to 365 days of age
Pediatric Quality of Life Family Impact Module	questionnaire	up to 365 days of age
Pediatric Quality of Life Inventory Infant Scales	Questionnaire. A 5-point response scale is utilized (0 = never a problem; 4 = always a problem). Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher scores indicate better functioning (less negative impact).	120, 180, 275, and 365 days of age
Medically confirmed adverse events collected throughout the study period		up to 365 days of age
Specific medically confirmed adverse events related to gastrointestinal		up to 365 days of age
Specific medically confirmed adverse events related to allergy		up to 365 days of age
Body weight		up to 365 days of age

Collaborators and Investigators

• Sponsor: Mead Johnson Nutrition
• Investigators: Study Director: Steven Wu, Medical Director, Mead Johnson Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2021
• Primary Completion (Actual): October 11, 2022
• Study Completion (Actual): November 21, 2023

Study Registration Dates

• First Submitted: September 8, 2021
• First Submitted That Met QC Criteria: September 8, 2021
• First Posted (Actual): September 17, 2021

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Caseins
• Other Study ID Numbers: 3391-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No