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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
32
Donor breast milk will be given to the newborn if supplementation is required
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Santa Monica-UCLA
Los Angeles, California, United States
Study Feasibility_1
Feasibility will be evaluated by: consent rate
Time frame: 6-8 weeks chronological age
Study Feasibility_2
Feasibility will be evaluated by: study completion rate
Time frame: 6-8 weeks chronological age
Study Feasibility_3
Feasibility will be evaluated by: rate of adherence to the study diet.
Time frame: 6-8 weeks chronological age
Percentage of Human Milk Consumption at Discharge
Maternal milk/total milk (percent) consumed by the neonate over 48 hours
Time frame: at the time of NICU discharge or 7 days of age, whichever is later
Percentage of Human Milk Consumption After Discharge
Maternal milk/total milk (percent) consumed by the infant over 48 hours
Time frame: 6-8 weeks chronological age
Breastfeeding duration
time infant received breastmilk since birth
Time frame: 6-8 weeks chronological age
Intent to Breastfeed
Mother's desire to continue to breastfeed: specifically assessed by asking the mother if she plans to exclusively breastfeed or not. Answers will be recorded as yes or no.
Time frame: 6-8 weeks chronological age
Growth: Weight
Weight in kilograms reported as a z-score
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Time frame: 6-8 weeks chronological age
Growth: Height
height in centimeters reported as a z-score
Time frame: 6-8 weeks chronological age
Growth: Head Circumference
head circumference in centimeters reported as a z-score
Time frame: 6-8 weeks chronological age