Dextrose Gel Does Not Prevent Neonatal Hypoglycemia

Phase 2

Completed

• Conditions: Infant, Small for Gestational Age; Complication of Prematurity; Intrauterine Growth Restriction; Premature Birth of Newborn; Fetal Macrosomia; Hypoglycemia; Neonatal Hypoglycemia
• Interventions: Dietary Supplement: 40% Dextrose gel

• Registration Number: NCT02523222
• Lead Sponsor: Baylor College of Medicine

Brief Summary

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

Detailed Description

OBJECTIVE: To test the hypothesis that prophylactic dextrose gel administered to newborns at risk for hypoglycemia will increase the initial blood glucose (BG) concentration after the first feeding and subsequently decrease NICU admissions for treatment of asymptomatic transient neonatal hypoglycemia (TNH) vs those given feedings alone.

STUDY DESIGN: This quasi-experimental pilot study allocated asymptomatic at-risk newborns (late preterm, birth weight \<2500 or \>4000 g, and infants of diabetic mothers) to receive prophylactic dextrose gel (Insta-Glucose®); other at-risk newborns served as controls. After the initial feeding, the prophylactic group received dextrose gel (0.5 ml/kg) rubbed into the buccal mucosa, and BG was checked 30 min later. Initial BG concentrations and rate of NICU admissions (for treatment of hypoglycemia) were compared between the prophylactic group and controls using the Wilcoxon rank-sum test and Fisher's exact test, where appropriate. A multivariable linear regression compared first BG between groups after adjusting for at-risk categories and age at first BG concentration.

Study Timeline

• Study First Submitted: 2015-08-12
• Study First Submitted QC: 2015-08-12
• Study First Posted: 2015-08-14
• Study Start: 2016-07-01
• Primary Completion: 2018-03-01
• Study Completion: 2018-07-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

Inclusion Criteria

• Gestational age above 35 weeks
• Infants less than 1 hour of age
• Infants with informed parental consent
• Infants who are born at the Harris Health Ben Taub Hospital in Houston, TX

Exclusion Criteria

• Infants with known metabolic, genetic, or congenital anomalies
• Infants not expected to survive the neonatal period
• Infants determined later to have a metabolic, genetic, or congenital anomaly that was not immediately obvious in the newborn period
• Hypoglycemic infants with symptoms
• Infants transferred to the Level 3 NICU for other reasons

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dextrose Gel	40% Dextrose gel	Infants given 40% Dextrose gel (0.5ml/kg) in the buccal mucosa after their first feed, within the first hour of life.

Primary Outcome Measures

Name	Time	Method
Prophylactic administration of dextrose gel	2 hours	Give infants who meet criteria for high-risk and whose parents have consented one dose of prophylactic 40% dextrose gel (0.5ml/kg) after first feed. Assess glucose level after 1 feed and 1 application of dextrose gel, and admission to the NICU, compared to controls with similar risk factors who are not treated prophylactically.
Treatment failure of at-risk infants	4 days	Infants at-risk (IDM, late preterm, SGA, LGA, estimated fetal weight below 2.5kg or above 4kg, IUGR, or poor feeding) will be followed until hospital discharge to measure NICU admission data and glucose values during hospitalization.

Trial Locations

Locations (1)

Ben Taub Harris Health Hospital; 🇺🇸 Houston, Texas, United States