Clinical trial NCT04572581: Donor Breast Milk and Breastfeeding Rates
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding, Exclusive
Breastfeeding
Keywords: Late Preterm
Donor Breast Milk
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 32
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Study Feasibility_1
timeFrame: 6-8 weeks chronological age
measure: Study Feasibility_2
timeFrame: 6-8 weeks chronological age
measure: Study Feasibility_3
timeFrame: 6-8 weeks chronological age
Secondary outcomes:
measure: Percentage of Human Milk Consumption at Discharge
timeFrame: at the time of NICU discharge or 7 days of age, whichever is later
measure: Percentage of Human Milk Consumption After Discharge
timeFrame: 6-8 weeks chronological age
measure: Breastfeeding duration
timeFrame: 6-8 weeks chronological age
measure: Intent to Breastfeed
timeFrame: 6-8 weeks chronological age
measure: Growth: Weight
timeFrame: 6-8 weeks chronological age
measure: Growth: Height
timeFrame: 6-8 weeks chronological age
measure: Growth: Head Circumference
timeFrame: 6-8 weeks chronological age
Other outcomes:
measure: Intestinal Microbiome: microbial profiling (genus level)
timeFrame: 7 days of age
measure: Intestinal Microbiome: alpha diversity (Chao1)
timeFrame: 7 days of age
Locations:
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Los Angeles
country: United States
facility: Santa Monica-UCLA
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Kara L Calkins, MD
role: PRINCIPAL_INVESTIGATOR
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