Nutritive Effects of Cow's Milk-Based Formulas Through 18 Months of Age

Mead Johnson Nutrition1 site in 1 country1 target enrollmentAugust 5, 2021

ConditionsNutritive Effects on Brain Myelination

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Nutritive Effects on Brain Myelination
Sponsor: Mead Johnson Nutrition
Enrollment: 1
Locations: 1
Primary Endpoint: MR Imaging
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This clinical trial will assess nutritive effects on brain myelination in infants assigned to receive one of two study formula or mother's own breast milk through 18 month's of age.

Registry

clinicaltrials.gov

Start Date

August 5, 2021

End Date

September 7, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Mead Johnson Nutrition

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Singleton birth
•Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks gestational age)
•Birth weight of 2500 g (5 lbs 8 oz) or more
•Parent(s) or legal guardian agrees not to enroll infant in another interventional clinical study while participating in this study
•Signed informed consent obtained for infant's participation in the study
•Signed authorization obtained to use and/or disclose Protected Health Information for infant from birth through 18 months of age
•Infants receiving formula:
•3 to 60 days of age at randomization, inclusive (day of birth is considered day 0)
•Exclusively receiving infant formula for at least 72 hours prior to randomization
•Parent(s) or legal guardian has full intention to exclusively feed study formula during the study period

Exclusion Criteria

•Contraindication to magnetic resonance imaging (MRI)
•First degree relative with known autism, intellectual disability, schizophrenia, or bipolar disorder or an inherited disorder of myelination
•Major pre- and/or perinatal issues (such as maternal pre-eclampsia, placental abruption, maternal alcohol or illicit drug use during pregnancy)
•Major delivery complications (such as neonatal hypoxia or neonatal illness requiring a greater than 2-day NICU stay)
•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)
•5 minute APGAR \< 7
•Infant was born large for gestational age (LGA) (as confirmed by the hospital birth records) from mother who was diabetic at childbirth
•Infant has been identified with inadequate weight gain or failure to thrive by a health care professional (HCP)
•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
•Parent(s) or legal guardian unable to speak English at a level to provide informed consent

Outcomes

Primary Outcomes

MR Imaging

Time Frame: 365 days of age

Brain Imaging

Secondary Outcomes

Body Weight(180, 365 and 545 days of age)
MR Imaging(180 and 545 days of age)
Visual Expectation Paradigm(180 and 365 days of age)
Bayley Scales of Infant and Toddler Development, Third Edition(365 and 545 days of age)
Head Circumference(180, 365 and 545 days of age)
Stool Microbiome Composition(180, 365 and 545 days of age)
Medically confirmed Adverse Events(Through study completion, on average 18 months)
A-not-B Task(365 and 545 days of age)
Length(180, 365 and 545 days of age)
Gap Overlap Paradigm(180 and 365 days of age)
Recall of Study Feeding(180, 275 (HM Reference group only), 365 and 545 days of age)