Clinical trial NCT04030312: Effectiveness of Donor Human Milk Supplementation for the Treatment of Hypoglycemia in the Breastfed Infant
Official title: Effectiveness of Donor Human Milk Supplementation Compared to Infant Formula for the Treatment of Hypoglycemia in the Breastfed Infant in the Normal Newborn Nursery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Hypoglycemia
Keywords: neonatal
newborn
hypoglycemia
human milk
breastfed
donor milk
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 18
Sex: ALL
Minimum age (years): 1
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare if newborn infant hypoglycemia can be improved with bottle supplementation of commercially-sterilized donor human milk compared to standard infant formula. Hypothesis is that supplementation with commercially-sterilized donor human milk will improve hypoglycemia and limit formula use in exclusively breastfed infants.

Detailed description: Enrolled infant participants will receive a maximum of two bottle feeding supplementations (of their designated treatment arm for either 20 calorie-per-ounce commercially-sterilized donor human milk OR 20-calorie-per-ounce standard infant formula) as treatment if they meet hypoglycemia criteria. Infant participants will complete the study if 1) they have received two bottle feeding supplementations for treatment of hypoglycemia, 2) they only received one bottle supplementation and hypoglycemia resolved, 3) if the medical teams deems the infants requires a higher level of care for their hypoglycemia (example: admission to the newborn intensive care unit for intravenous fluids with dextrose).

Eligibility criteria: Mother-infant pairs will be consented for participation via informed written consent.

Inclusion Criteria:

* Mother/infant dyads deliverying at Nebraska Medicine hospital (Omaha, NE, USA).
* Infant in the normal newborn nursery, born greater than or equal to 36 weeks gestational age.
* Infant with blood glucose after delivery of \< 40 milligrams/deciliter within the first four hours of life OR blood glucose levels less than 45 milligrams/deciliter after four hours of life
* Deliverying mother plans to exclusively breastfeed.

Exclusion Criteria:

* Infants born and directly admitted to the newborn intensive care unit
* Infants with known congenital abnormality or known inborn error of metabolism that influences growth and metabolic outcomes
* Infants deemed ward of state
* Mothers who do not plan to exclusively breastfeed at time of delivery
* Mothers less than 19 years of age

Primary outcomes:
measure: Effectiveness of Resolving Neonatal Hypoglycemia: Blood glucose levels
timeFrame: Blood glucose levels will be monitored within 60 minutes of initiating a feeding. Overall outcomes for each treatment arm will be compared at the completion of the study for all enrolled participants.
Secondary outcomes:
measure: Exclusive Breastfeeding Duration
timeFrame: Families of consented participants will be contacted when the enrolled infant is 6 months old.
measure: Parenteral Satisfaction of Infant Feeding: Parenteral satisfaction surveys
timeFrame: Parenteral satisfaction surveys will be completed prior to mother's hospital discharge (within 72 hours following delivery).
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: Nebraska Medicine
name: Melissa K Thoene, RD, PhD
role: PRINCIPAL_INVESTIGATOR
References: