Use of Human Milk-Based Diet in the Late Preterm and Term Infant in the Neonatal Intensive Care Unit: A Pilot Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breastfeeding, Exclusive
- Sponsor
- University of California, Los Angeles
- Enrollment
- 32
- Locations
- 2
- Primary Endpoint
- Study Feasibility_1
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Detailed 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.
Investigators
Kara L. Calkins, MD
Health Sciences Clinical Assistant Professor, Pediatric Neonatology
University of California, Los Angeles
Eligibility Criteria
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
Outcomes
Primary Outcomes
Study Feasibility_1
Time Frame: 6-8 weeks chronological age
Feasibility will be evaluated by: consent rate
Study Feasibility_2
Time Frame: 6-8 weeks chronological age
Feasibility will be evaluated by: study completion rate
Study Feasibility_3
Time Frame: 6-8 weeks chronological age
Feasibility will be evaluated by: rate of adherence to the study diet.
Secondary Outcomes
- Growth: Height(6-8 weeks chronological age)
- Percentage of Human Milk Consumption at Discharge(at the time of NICU discharge or 7 days of age, whichever is later)
- Percentage of Human Milk Consumption After Discharge(6-8 weeks chronological age)
- Growth: Head Circumference(6-8 weeks chronological age)
- Breastfeeding duration(6-8 weeks chronological age)
- Growth: Weight(6-8 weeks chronological age)
- Intent to Breastfeed(6-8 weeks chronological age)