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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
1
Cow's milk-based formula
Cow's milk-based formula with added source of enriched whey protein
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
MR Imaging
Brain Imaging
Time frame: 365 days of age
MR Imaging
Brain Imaging
Time frame: 180 and 545 days of age
Gap Overlap Paradigm
Time frame: 180 and 365 days of age
Visual Expectation Paradigm
Time frame: 180 and 365 days of age
A-not-B Task
Time frame: 365 and 545 days of age
Bayley Scales of Infant and Toddler Development, Third Edition
Time frame: 365 and 545 days of age
Body Weight
Time frame: 180, 365 and 545 days of age
Length
Time frame: 180, 365 and 545 days of age
Head Circumference
Time frame: 180, 365 and 545 days of age
Recall of Study Feeding
Feeding Questionnaire
Time frame: 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)
Time frame: 180, 365 and 545 days of age
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Medically confirmed Adverse Events
Time frame: Through study completion, on average 18 months