Acceptance of a Partially Hydrolyzed Formula

NCT ID: NCT05245422

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-28
• Study Completion Date: 2023-07-14

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.

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.

Conditions

Fussy Infant (Baby)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Cow's milk intact protein infant formula

Control

Group Type: ACTIVE_COMPARATOR

Infant Formula - Intact protein

Intervention Type: OTHER

Intact cow's milk protein

Partially hydrolyzed cow's milk protein infant formula

Investigational

Group Type: EXPERIMENTAL

Infant Formula - Partially hydrolyzed protein

Intervention Type: OTHER

Partially hydrolyzed cow's milk protein

Interventions

Infant Formula - Partially hydrolyzed protein

Partially hydrolyzed cow's milk protein

Intervention Type: OTHER

Infant Formula - Intact protein

Intact cow's milk protein

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 15 Days
• Maximum Eligible Age: 75 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mead Johnson Nutrition

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Birmingham Pediatric Associates

Birmingham, Alabama, United States

Alabama Clinical Therapeutics

Birmingham, Alabama, United States

DBC Research USA

Miramar, Florida, United States

Proactive Clinical Research

Sarasota, Florida, United States

Mid Valley Research Inc.

Moline, Illinois, United States

Frontier Pediatric Research

Lincoln, Nebraska, United States

Meridian Clinical Research

Charleston, South Carolina, United States

Tribe Clinical Research

Greenville, South Carolina, United States

AVIATI Healthcare & Clinical Research

Memphis, Tennessee, United States

South Texas Pediatric Research Group

Del Rio, Texas, United States

Proactive Clinical Research

Edinburg, Texas, United States

Countries

United States

Other Identifiers

3392-1

Identifier Type: -

Identifier Source: org_study_id