Acceptance of a Partially Hydrolyzed Formula

Parent And Infant Relief (PAIR): Acceptance of a Partially Hydrolyzed Formula

A multi-center, double-blind, controlled, parallel-designed, prospective trial intended to evaluate the nutritive effects of a partially hydrolyzed cow's milk protein infant formula on infant fussiness.

Study Overview

• Status: Completed
• Conditions: Fussy Infant (Baby)
• Intervention / Treatment: Other: Infant Formula - Intact protein; Other: Infant Formula - Partially hydrolyzed protein

Detailed Description

A multi-center, double-blind, controlled, parallel-designed, prospective trial intended to evaluate the nutritive effects of a partially hydrolyzed cow's milk protein (PHP) infant formula on infant fussiness. Formula tolerance and intake, sleep characteristics, stool characteristics, parental quality of life, and medically confirmed adverse events will be compared between i two study groups.

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Birmingham Pediatric Associates
    • Birmingham, Alabama, United States, 35235
      • Alabama Clinical Therapeutics
  • Florida
    • Miramar, Florida, United States, 33025
      • DBC Research USA
    • Sarasota, Florida, United States, 34243
      • Proactive Clinical Research
  • Illinois
    • Moline, Illinois, United States, 61265
      • Mid Valley Research Inc.
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Frontier Pediatric Research
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Meridian Clinical Research
    • Greenville, South Carolina, United States, 29607
      • Tribe Clinical Research
  • Tennessee
    • Memphis, Tennessee, United States, 38115
      • AVIATI Healthcare & Clinical Research
  • Texas
    • Del Rio, Texas, United States, 78840
      • South Texas Pediatric Research Group
    • Edinburg, Texas, United States, 78539
      • Proactive Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 3 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Primary caregiver has reliable access to the internet and a reliable device (such as a computer, tablet, or smartphone) to access mobile apps and be able to view and complete study questionnaires
• Singleton birth
• 15 to 75 days of age at Visit 1, inclusive (day of birth is considered Day 0)
• Gestational age of ≥37 to 42 weeks (36 weeks and six days is considered 36 weeks' gestational age)
• Birth weight of 2500 g (5 lbs 8 oz) or more
• Exclusively receiving an intact protein infant formula (cow's milk-based or plant-based) for 7 days prior to Visit 1
• Answer to question: "On average, how fussy has your baby been over the past 3 days" is moderately fussy, very fussy, or extremely fussy at Visit 1
• Parent(s) or legal guardian has full intention to exclusively feed study formula during the study period
• Parent(s) or legal guardian agrees not to enroll infant in another interventional clinical study while participating in this study
• Signed informed consent obtained from parent or legal guardian for infant's participation in the study
• Signed authorization obtained from parent or legal guardian to use and/or disclose Protected Health Information for infant from birth through the length of the study period

Exclusion Criteria:

• Infant has been weighed by a health care professional (HCP) and is identified with inadequate weight gain or failure-to-thrive
• Diagnosis or suspicion of cow's milk protein allergy by a healthcare professional
• Any acute illness within the 3 days prior to Visit 1
• Infant has had immunizations or a surgical procedure within the 3 days prior to or on Visit 1
• Immunizations are planned for the infant during any of the 7 days after Visit 1
• Use of oral, intramuscular or intravenous antibiotics within the 7 days prior to Visit 1
• Infant has had bloody stools (visible to the naked eye) within the 7 days prior to Visit 1
• Infant has been taking medication (prescribed and over-the-counter) for gastrointestinal conditions for any of the 7 days prior to Visit 1 (however, probiotics are allowed)
• Infant has a surgical procedure planned during the study period
• History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant
• History of underlying neurological or organic disease likely to cause fussiness, such as (but not limited to) a doctor's diagnosis of neonatal abstinence syndrome and inflammatory or orthopedic disorders
• Infant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as combined immunodeficiencies, DiGeorge syndrome, Wiskott-Aldrich syndrome, severe congenital neutropenia and secondary immunodeficiencies linked to HIV infection, Down syndrome or others)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cow's milk intact protein infant formula; Control	Other: Infant Formula - Intact protein; Intact cow's milk protein
Experimental: Partially hydrolyzed cow's milk protein infant formula; Investigational	Other: Infant Formula - Partially hydrolyzed protein; Partially hydrolyzed cow's milk protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fussiness	Daily Diary	Study Feeding Days 1 through 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fussiness	Daily Diary	Study Feeding Days 8-28
Study Formula Intake	24-hour Recall of Study Formula Intake	Study Feeding Day 7 and Study Feeding Day 25 (+3 days)
Brief Infant Sleep Questionnaire	Revised Short Form (BISQ-R SF)	Study Feeding Day 14 (+2 days) and Study Feeding Day 25 (+ 3 days)
Quality of Life Questionnaire	Pediatric Quality of Life Inventory™ Family Impact Module (PedsQL FIM)-Acute	Study Feeding Day 7 (+2 days) and Study Feeding Day 25 (+3 days)
Medically confirmed adverse events	Collected from medical records	Day 1 through end of feeding
Gassiness	Daily Diary	Study Feeding Days 1-28
Crying	Daily Diary	Study Feeding Days 1-28
Spit-up	Daily Diary	Study Feeding Days 1-28
Sleep	Daily Diary	Study Feeding Days 1-28
Stool frequency	Daily Diary	Study Feeding Days 1-28
Stool consistency	Daily Diary	Study Feeding Days 1-28

Collaborators and Investigators

• Sponsor: Mead Johnson Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2022
• Primary Completion (Actual): July 14, 2023
• Study Completion (Actual): July 14, 2023

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: February 4, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Actual): June 18, 2025
• Last Update Submitted That Met QC Criteria: June 13, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 3392-1

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
• product manufactured in and exported from the U.S.: No