Donor Breast Milk
OtherDonor breast milk will be given to the newborn if supplementation is required
NCT Number: NCT04572581
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.
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All sexes
Interventional
Not applicable
Ronald Reagan UCLA Medical Center, Los Angeles, California, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Donor breast milk will be given to the newborn if supplementation is required
Time frame: 6-8 weeks chronological age
Feasibility will be evaluated by: consent rate
Time frame: 6-8 weeks chronological age
Feasibility will be evaluated by: study completion rate
Time frame: 6-8 weeks chronological age
Feasibility will be evaluated by: rate of adherence to the study diet.
Time frame: at the time of NICU discharge or 7 days of age, whichever is later
Maternal milk/total milk (percent) consumed by the neonate over 48 hours
Time frame: 6-8 weeks chronological age
Maternal milk/total milk (percent) consumed by the infant over 48 hours
Time frame: 6-8 weeks chronological age
time infant received breastmilk since birth
Time frame: 6-8 weeks chronological age
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
Weight in kilograms reported as a z-score
Time frame: 6-8 weeks chronological age
height in centimeters reported as a z-score
Time frame: 6-8 weeks chronological age
head circumference in centimeters reported as a z-score
Time frame: 7 days of age
Microbial profiling (genus level) will be investigated by sequencing of the V4 region of the 16S ribosomal ribonucleic acid gene
Time frame: 7 days of age
Alpha diversity (Chao1) will be investigated by sequencing of the V4 region of the 16S ribosomal ribonucleic acid gene
University of California, Los Angeles
Other
Use of Human Milk-Based Diet in the Late Preterm and Term Infant in the Neonatal Intensive Care Unit: A Pilot Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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