Clinical Trials Logo
  1. Home
  2. Neonatal Hypoglycemia
  3. NCT04030312

Effectiveness of Donor Human Milk Supplementation for the Treatment of Hypoglycemia in the Breastfed Infant

Neonatal Hypoglycemia Clinical Trial

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

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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04030312
Study type Interventional
Source University of Nebraska
Contact
Status Completed
Phase N/A
Start date May 1, 2020
Completion date April 10, 2023
View Details
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
Recruiting 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
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
Not yet recruiting NCT02838875 - To Examine if the Mother's Glucose Levels and Glucose Levels in the Blood Can Predict Cord Hypoglycemia in Newborns at Risk. Phase 3