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

Study Overview
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Brief Summary
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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.

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

Conditions
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Nutritive Effects on Brain Myelination

Intervention / Treatment
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* Other: Control
* Other: Investigational


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Days
Maximum Age: 180 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 |