Clinical trial NCT04859231: Nutritive Effects of Cow's Milk-Based Formulas Through 18 Months of Age
Official title: Nutritive Effects of Cow's Milk-Based Formulas Through 18 Months of Age
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Nutritive Effects on Brain Myelination
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
Collaborators: name: University of North Carolina, Chapel Hill
First posted: 2021-04-26
Enrollment: 1
Sex: ALL
Minimum age (years): 3
Maximum age (years): 180
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

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

Primary outcomes:
measure: MR Imaging
timeFrame: 365 days of age
Secondary outcomes:
measure: MR Imaging
timeFrame: 180 and 545 days of age
measure: Gap Overlap Paradigm
timeFrame: 180 and 365 days of age
measure: Visual Expectation Paradigm
timeFrame: 180 and 365 days of age
measure: A-not-B Task
timeFrame: 365 and 545 days of age
measure: Bayley Scales of Infant and Toddler Development, Third Edition
timeFrame: 365 and 545 days of age
measure: Body Weight
timeFrame: 180, 365 and 545 days of age
measure: Length
timeFrame: 180, 365 and 545 days of age
measure: Head Circumference
timeFrame: 180, 365 and 545 days of age
measure: Recall of Study Feeding
timeFrame: 180, 275 (HM Reference group only), 365 and 545 days of age
measure: Stool Microbiome Composition
timeFrame: 180, 365 and 545 days of age
measure: Medically confirmed Adverse Events
timeFrame: Through study completion, on average 18 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
References: