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

NCT ID: NCT04859231

Last Updated: 2022-01-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-05
• Study Completion Date: 2021-09-07

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Control

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

Cow's milk-based formula

Investigational

Group Type: EXPERIMENTAL

Investigational

Intervention Type: OTHER

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

Mother's-own Breast Milk

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Control

Cow's milk-based formula

Intervention Type: OTHER

Investigational

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 3 Days
• Maximum Eligible Age: 180 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

Mead Johnson Nutrition

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37929831 (View on PubMed)

Other Identifiers

6042

Identifier Type: -

Identifier Source: org_study_id