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

NCT04859231 | Terminated

• 1 other identifier: 6042
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutritive Effects on Brain Myelination

Outcome Measures

Primary Outcomes (1)

• MR Imaging

  Brain Imaging

  365 days of age

Secondary Outcomes (11)

• MR 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

Study Arms (3)

Control

ACTIVE COMPARATOR

Other: Control

Investigational

EXPERIMENTAL

Other: Investigational

Mother's-own Breast Milk

NO INTERVENTION

Interventions

Control OTHER

Cow's milk-based formula

Control

Investigational OTHER

Cow's milk-based formula with added source of enriched whey protein

Investigational

Eligibility Criteria

• Age: 3 Days - 180 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• 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:
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Mead Johnson Nutrition: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• Gonzalez-Garay AG, Serralde-Zuniga AE, Medina Vera I, Velasco Hidalgo L, Alonso Ocana MV. Higher versus lower protein intake in formula-fed term infants. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD013758. doi: 10.1002/14651858.CD013758.pub2.

  PMID: 37929831 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 26, 2021
• Study Start: August 5, 2021
• Primary Completion: September 7, 2021
• Study Completion: September 7, 2021
• Last Updated: January 3, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)