Donor Breast Milk and Breastfeeding Rates

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Breastfeeding; Breastfeeding, Exclusive

Treatments: Other: Donor Breast Milk

Study type: Interventional

Funder types: Other

Identifiers

NCT04572581

19-002179

Details and patient eligibility

About

The purpose of this pilot study is to determine if a randomized controlled study comparing a human milk diet versus a formula supplemented diet in late preterm and term infants in the neonatal intensive care unit (NICU) is feasible.

Full description

In late preterm infants and term neonates in the NICU whose mothers intend to breastfeed, this pilot study seeks to 1. determine study feasibility (consent rate, study completion rate, and rate of adherence to study diet), and 2. determine whether a dietary supplementation with donor human milk vs. formula improves: a. the percentage of maternal milk consumption at time of discharge from the NICU, or 7 days of age, whichever is later, b. breastfeeding rates and intent to breastfeed at 6-8 weeks chronological age, and c. breast feeding duration.

Enrollment: 32 patients

Sex: All

Ages: Under 3 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gestational age >34 weeks and 0 days
• Mother's intent to breast feed
• NICU admission which is predicted to be at least 72 hours from time of admission

Exclusion criteria

• Confirmed genetic disorders and syndromes or other disorders known to affect growth and ability to bottle feed or breast feed (i.e., Trisomies)
• Common neonatal congenital anomalies (cardiac disease, congenital gastrointestinal disorders, etc)
• Commonly accepted contraindications for breast feeding (HIV, galactosemia, herpes lesions on the breast, maternal use of drugs that are considered contraindicated with breast feeding including marijuana)
• Infant admitted to the intensive care unit who is receiving invasive respiratory support (intubation) and/or ionotropic medications
• Any infant whose care is considered futile by the primary medical team

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Exclusively Human Milk Diet

Experimental group

Description:

This group will receive human milk only. If the mother is not producing enough breast milk, this group will receive donor milk supplementation.

Treatment:

Other: Donor Breast Milk

Formula-based Diet

No Intervention group

Description:

If the mother is not producing enough breast milk, this group will receive formula supplementation (the standard of care).