Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04030312
Other study ID # 0119-19-EP
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2020
Est. completion date April 10, 2023

Study information

Verified date September 2023
Source University of Nebraska
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date April 10, 2023
Est. primary completion date July 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Minute to 72 Hours
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Bottle Supplementation--Commercially-Sterilized Donor Human Milk
Supplementation by bottle with 20-calorie-per-ounce commercially-sterilized donor human milk (up to 15 ml, up to two times) for infants meeting hypoglycemia criteria and randomized to this treatment arm.
Bottle Supplementation--Standard Infant Formula
Supplementation by bottle with 20-calorie-per-ounce standard infant formula (up to 15 ml, up to two times) for infants meeting hypoglycemia criteria and randomized to this treatment arm.

Locations

Country Name City State
United States University of Nebraska Medical Center Omaha Nebraska

Sponsors (1)

Lead Sponsor Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effectiveness of Resolving Neonatal Hypoglycemia: Blood glucose levels To compare the effectiveness of commercially-sterilized donor human milk bottle supplementation for the treatment of hypoglycemia in the breastfed infant in the normal newborn nursery compared to bottle supplementation with standard infant formula. 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 Exclusive Breastfeeding Duration To assess if donor human milk supplementation (when compared to formula supplementation) impacts rate of exclusive breastfeeding during the first 6 months of life. Families of consented participants will be contacted when the enrolled infant is 6 months old.
Secondary Parenteral Satisfaction of Infant Feeding: Parenteral satisfaction surveys To compare if donor human milk supplementation (when compared to formula supplementation) improves parental satisfaction related to infant feeding during post-partum hospitalization. Parenteral satisfaction surveys will be completed prior to mother's hospital discharge (within 72 hours following delivery).
See also
  Status Clinical Trial Phase
Completed NCT02583776 - Continuous Glucose Monitoring and Preterm Infants Phase 4
Not yet recruiting NCT05977972 - Pattern of Metabolic Causes of Neonatal Hypoglycemia
Recruiting NCT04458649 - Continuous Glucose Monitoring in Infants
Recruiting NCT05127070 - Evaluating the NeoTree in Malawi and Zimbabwe
Completed NCT03032523 - Detecting Neonatal Hypoglycemia Using Real-Time Continuous Glucose Monitoring (CGM) N/A
Completed NCT03726697 - Effect of Tahneek on Hypoglycemia in Newborn Infants N/A
Terminated NCT04085978 - Effects of a Hypoglycemia Protocol With Glucose Gel on Neonatal Intensive Care Unit (NICU) Admission
Terminated NCT05647798 - Intrapartum Glycemic Control in GDMA2 N/A
Not yet recruiting NCT04811612 - Comparing Heel Stick Glucoses in Neonates N/A
Not yet recruiting NCT02648555 - A Lifestyle Intervention to Improve in Vitro Fertilization Results N/A
Recruiting NCT06373432 - Frequency of Glucose Monitoring in Labor N/A
Completed NCT03076775 - Euglycemia After Antenatal Late Preterm Steroids, the E-ALPS Study N/A
Completed NCT05022433 - Comparison of the Shukla and UN-1 Formulae in the Placement of the Umbilical Venous Catheter Among Neonates
Recruiting NCT00332449 - Early Breast Feeding and Glucose Levels in High Risk Newborns N/A
Not yet recruiting NCT04869709 - Late Preterm Corticosteroids and Neonatal Hypoglycemia Phase 4
Completed NCT02523222 - Prophylactic Dextrose Gel for Newborns at High-risk for Hypoglycemia N/A
Recruiting NCT04875624 - Neurodevelopment of Hypoglycemic Neonates
Completed NCT02605369 - SURVIVAL PLUSS: Increasing Capacity for Mama-baby Survival in Post-conflict Uganda and South Sudan N/A
Withdrawn NCT03738293 - Continuous Glucose Monitoring of Late Preterm Birth After Corticosteroids
Recruiting NCT04386005 - Continuous Glucose Monitoring in At-Risk Newborns N/A