Growth and Tolerance of a Partially Hydrolyzed Infant Formula

Mead Johnson Nutrition

Status

Completed

Conditions

Growth

Treatments

Other: Cow's milk protein infant formula

Other: Partially hydrolyzed protein infant formula

Study type

Interventional

Funder types

Industry

Identifiers

NCT05047978

3391-1

Details and patient eligibility

About

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.

Enrollment

244 patients

Sex

All

Ages

10 to 14 days old

Volunteers

Accepts Healthy Volunteers

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