Oral Dextrose Gel vs Standard Care for the Treatment of Hypoglycemia in High-Risk Neonates: An Open-Label Randomized Controlled Trial

Purpose: To determine whether 40% dextrose gel with oral feeds reduces NICU admission for asymptomatic hypoglycemia compared with standard care with oral feeds in at-risk neonates within 48 hours of life. Methods: Open-label randomized controlled trial conducted at a tertiary hospital in South India between April 2023 and May 2024. Neonates born at ≥35 weeks of gestation and identified with asymptomatic hypoglycemia within the first 48 hours of life were enrolled and randomly assigned to receive either 200 mg/kg of oral 40% dextrose gel, along with oral feeds, or standard care with oral feeds alone. Results: A total of 193 neonates were enrolled, with 98 in the standard care group and 95 in the gel group. Baseline characteristics were comparable. NICU admission due to hypoglycemia was lower in gel group (4.2%) versus the standard care group (12.2%), with a relative risk of 0.34 (95% CI: 0.11–1.03), p = 0.06, and a number needed to treat (NNT) of 13. Exclusive breastfeeding at discharge was higher in the gel group (97 % vs. 76%), and this difference persisted at six weeks (90% vs. 69%). The incidence of rebound, recurrent hypoglycemia, and hyperglycemia was similar in both groups. Conclusion: Oral dextrose gel reduces NICU admissions among at-risk neonates with asymptomatic hypoglycemia; however, this association was not statistically significant. It also improves exclusive breastfeeding rates at both hospital discharge and at the six-week follow-up.​ Trial registration: Clinical Trials Registry of India (CTRI/2023/02/050027)