Acceptance of a Partially Hydrolyzed Formula

NCT05245422 | Completed

• 1 other identifier: 3392-1
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Fussy Infant (Baby)

Outcome Measures

Primary Outcomes (1)

• Fussiness

  Daily Diary

  Study Feeding Days 1 through 7

Secondary Outcomes (11)

• Fussiness

  Study Feeding Days 8-28

• Gassiness

  Study Feeding Days 1-28

• Crying

  Study Feeding Days 1-28

• Spit-up

  Study Feeding Days 1-28

• Sleep

  Study Feeding Days 1-28

Study Arms (2)

Cow's milk intact protein infant formula

ACTIVE COMPARATOR

Control

Other: Infant Formula - Intact protein

Partially hydrolyzed cow's milk protein infant formula

EXPERIMENTAL

Investigational

Other: Infant Formula - Partially hydrolyzed protein

Interventions

Infant Formula - Partially hydrolyzed protein OTHER

Partially hydrolyzed cow's milk protein

Partially hydrolyzed cow's milk protein infant formula

Infant Formula - Intact protein OTHER

Intact cow's milk protein

Cow's milk intact protein infant formula

Eligibility Criteria

• Age: 15 Days - 75 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mead Johnson Nutrition: lead

Study Sites (11)

Birmingham Pediatric Associates

Birmingham, Alabama, 35205, United States

Location

Alabama Clinical Therapeutics

Birmingham, Alabama, 35235, United States

Location

DBC Research USA

Miramar, Florida, 33025, United States

Location

Proactive Clinical Research

Sarasota, Florida, 34243, United States

Location

Mid Valley Research Inc.

Moline, Illinois, 61265, United States

Location

Frontier Pediatric Research

Lincoln, Nebraska, 68502, United States

Location

Meridian Clinical Research

Charleston, South Carolina, 29414, United States

Location

Tribe Clinical Research

Greenville, South Carolina, 29607, United States

Location

AVIATI Healthcare & Clinical Research

Memphis, Tennessee, 38115, United States

Location

South Texas Pediatric Research Group

Del Rio, Texas, 78840, United States

Location

Proactive Clinical Research

Edinburg, Texas, 78539, United States

Location

Related Publications (1)

• Fabrizio V, Bohan Brown MM, Boucher P, Boyd S, Cao S, Davis C, Johnson S, Khan N, Moore N, Muse K, Ogwara F, Patterson AC, Wampler JL, Yeiser M, Zhuang W, Wu SS. A Randomized Controlled Trial of a Partially Hydrolyzed Formula on Comfort Measures in Fussy Infants. Curr Dev Nutr. 2025 Oct 13;9(11):107574. doi: 10.1016/j.cdnut.2025.107574. eCollection 2025 Nov.

  PMID: 41323693 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: February 18, 2022
• Study Start: February 28, 2022
• Primary Completion: July 14, 2023
• Study Completion: July 14, 2023
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)