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

Mead Johnson Nutrition12 sites in 1 country244 target enrollmentAugust 28, 2021

ConditionsGrowth

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Growth
Sponsor: Mead Johnson Nutrition
Enrollment: 244
Locations: 12
Primary Endpoint: Rate of body weight gain
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 28, 2021

End Date

November 21, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Mead Johnson Nutrition

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Rate of body weight gain

Time Frame: up to 120 days

Secondary Outcomes

Head circumference(up to 365 days of age)
Growth Z scores(up to 365 days of age)
Recall of study formula intake measured at each study visit(up to 365 days of age)
Pediatric Quality of Life Family Impact Module(up to 365 days of age)
Body weight(up to 365 days of age)
Body length(up to 365 days of age)
Recall of stool characteristics measured at each study visit(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)
Pediatric Quality of Life Inventory Infant Scales(120, 180, 275, and 365 days of age)
Medically confirmed adverse events collected throughout the study period(up to 365 days of age)