Summary

Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Kara L Calkins, MD (ucla)

Description

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.

Official Title

Use of Human Milk-Based Diet in the Late Preterm and Term Infant in the Neonatal Intensive Care Unit: A Pilot Randomized Controlled Trial

Details

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.

Keywords

Breastfeeding, Exclusive Breastfeeding Late Preterm Donor Breast Milk Formula-based Diet

Eligibility

You can join if…

  • 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

You CAN'T join if...

  • 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

Locations

  • Ronald Reagan UCLA Medical Center accepting new patients
    Los Angeles California 90025 United States
  • Santa Monica-UCLA accepting new patients
    Los Angeles California 90404 United States

Lead Scientist at University of California Health

  • Kara L Calkins, MD (ucla)
    HS Associate Clinical Professor, Pediatrics, Medicine. Authored (or co-authored) 35 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT04572581
Study Type
Interventional
Participants
Expecting 50 study participants
Last Updated