Prophylactic Dextrose Gel for Newborns at High-risk for Hypoglycemia

Hypoglycemia Clinical Trial

Official title: Prophylactic Dextrose Gel for Newborns at High-risk for Hypoglycemia

Status Completed

Clinical Trial Summary

This will be a quasi-experimental study comparing blood glucose values 30 minutes after feeding alone or feeding + 40% dextrose gel in newborns at risk for transient neonatal hypoglycemia.

Clinical Trial Description

BACKGROUND: Low blood sugar in newborns affects about 10% of all deliveries and about 50% of newborns with identified risk factors and is associated with poor long-term neurodevelopmental outcomes. Risk factors for transient neonatal hypoglycemia include infants of diabetic mothers, infants who are large or small for gestational age, infants with intrauterine growth restriction, and late-preterm infants.

GAP: Current standard of care recommends asymptomatic infants to receive intravenous dextrose after becoming hypoglycemic. International studies using dextrose gel have shown that the buccal mucosa is a promising alternative route, normalizes hypoglycemia, and decreases NICU admission. So far, no studies have published results about the efficacy of prophylactic dextrose gel.

HYPOTHESIS: We hypothesize that the prophylactic treatment of newborns at-risk for transient neonatal hypoglycemia with 40% dextrose gel will raise blood sugar levels by 15% compared to untreated controls. We hypothesize that 40% dextrose gel will prevent up to 50% of NICU admissions in this at-risk population compared to matched controls.

METHODS: This will be a quasi-experimental study. The study population will include babies born at Harris Health Ben Taub Hospital and have risk factors for transient neonatal hypoglycemia. After the baby completes its first feed, he or she will be given a dose of oral dextrose gel. A blood sugar level will be checked after 30 minutes, per standard of care. One hundred at-risk infants will be identified and have written parental consent prior to delivery and receiving the prophylactic treatment. Five hundred additional matched controls with similar risk factors will be analyzed for comparison and will not receive treatment.

RESULTS: Pending

IMPACT: If the study proves the hypotheses are correct, prophylactic dextrose gel could be implemented in newborn nurseries around the country to prevent transient hypoglycemia, decrease NICU admission (and its associated costs, painful procedures, and separation from family), improve feeding quality, and potentially optimize neurodevelopmental outcomes. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Complication of Prematurity
• Fetal Growth Retardation
• Fetal Macrosomia
• Hypoglycemia
• Infant, Small for Gestational Age
• Intrauterine Growth Restriction
• Neonatal Hypoglycemia
• Premature Birth
• Premature Birth of Newborn

• NCT number: NCT02523222
• Study type: Interventional
• Source: Baylor University
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Completion date: October 2016