Open Actively Recruiting

Donor Breast Milk and Breastfeeding Rates

About

Brief Summary

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.

Primary Purpose
Other
Study Type
Interventional
Phase
N/A

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
N/A
Maximum Age
3 Days

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 or nasal intermittent mechanical ventilation) and/or ionotropic medications
  • Any infant whose care is considered futile by the primary medical team

Join this Trial

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Study Stats
Protocol No.
19-002179
Category
Pediatrics
Principal Investigator
Contact
NEEMA PITHIA
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT04572581
For detailed technical eligibility, visit ClinicalTrials.gov.