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

Mead Johnson Nutrition10 sites in 1 country148 target enrollmentFebruary 28, 2022

ConditionsFussy Infant (Baby)

Overview

Phase: N/A
Intervention: Not specified
Conditions: Fussy Infant (Baby)
Sponsor: Mead Johnson Nutrition
Enrollment: 148
Locations: 10
Primary Endpoint: Fussiness
Status: Completed
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 28, 2022

End Date

July 14, 2023

Last Updated

10 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Mead Johnson Nutrition

Responsible Party

Sponsor

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

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

Outcomes

Primary Outcomes

Fussiness

Time Frame: Study Feeding Days 1 through 7

Daily Diary

Secondary Outcomes

Sleep(Study Feeding Days 1-28)
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)
Stool frequency(Study Feeding Days 1-28)
Stool consistency(Study Feeding Days 1-28)
Study Formula Intake(Study Feeding Day 7 and Study Feeding Day 25 (+3 days))
Brief Infant Sleep Questionnaire(Study Feeding Day 14 (+2 days) and Study Feeding Day 25 (+ 3 days))
Quality of Life Questionnaire(Study Feeding Day 7 (+2 days) and Study Feeding Day 25 (+3 days))
Medically confirmed adverse events(Day 1 through end of feeding)