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

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.

Study Overview

• Status: Terminated
• Conditions: Nutritive Effects on Brain Myelination
• Intervention / Treatment: Other: Control; Other: Investigational

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 days to 5 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Infants receiving human milk:

• 150-180 days of age at registration, inclusive (day of birth is considered day 0)
• Mother has intention to predominately provide mother's own breast milk through at least 10 months of age

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

Infants receiving formula:

• Evidence of feeding difficulties or history of formula intolerance, such as vomiting or poor intake at time of randomization

Infants receiving human milk:

• Use of infant formula and/or donor milk more than three times per week prior to registration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control	Other: Control; Cow's milk-based formula
Experimental: Investigational	Other: Investigational; Cow's milk-based formula with added source of enriched whey protein
No Intervention: Mother's-own Breast Milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MR Imaging	Brain Imaging	365 days of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MR Imaging	Brain Imaging	180 and 545 days of age
Gap Overlap Paradigm		180 and 365 days of age
Visual Expectation Paradigm		180 and 365 days of age
A-not-B Task		365 and 545 days of age
Bayley Scales of Infant and Toddler Development, Third Edition		365 and 545 days of age
Body Weight		180, 365 and 545 days of age
Length		180, 365 and 545 days of age
Head Circumference		180, 365 and 545 days of age
Recall of Study Feeding	Feeding Questionnaire	180, 275 (HM Reference group only), 365 and 545 days of age
Stool Microbiome Composition	Sequence analysis using QIIME 2.0 (quantitative insights into microbial ecology)	180, 365 and 545 days of age
Medically confirmed Adverse Events		Through study completion, on average 18 months

Collaborators and Investigators

• Sponsor: Mead Johnson Nutrition
• Collaborators: University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2021
• Primary Completion (Actual): September 7, 2021
• Study Completion (Actual): September 7, 2021

Study Registration Dates

• First Submitted: April 16, 2021
• First Submitted That Met QC Criteria: April 21, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): January 3, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 6042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No