Oral dextrose gel vs standard care for the treatment of hypoglycemia in high-risk neonates: an open-label randomized controlled trial

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 h of life. Secondary objectives were to assess rebound and recurrent hypoglycemia, hyperglycemia, and exclusive breastfeeding at discharge and at 6 weeks. 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 with asymptomatic hypoglycemia within the first 48 h of life were randomly assigned to receive either 200 mg/kg of oral 40% dextrose gel with oral feeds or standard care with oral feeds alone. The primary outcome was NICU admission for hypoglycemia. 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 for hypoglycemia occurred in 4.2% in gel group and 12.2% in standard care group (RR 0.34, 95% CI 0.11-1.03; p = 0.06), with a number needed to treat of 13. Exclusive breastfeeding was higher in gel group at discharge (97% vs 76%; p < 0.001) and at 6 weeks (90% vs 69%; p < 0.001). Rebound hypoglycemia, recurrent hypoglycemia, and hyperglycemia were similar between groups. CONCLUSION: Oral dextrose gel was associated with fewer NICU admissions, but the primary outcome did not reach statistical significance. Improved breastfeeding rates were observed as secondary outcomes. These findings should be interpreted cautiously and confirmed in adequately powered studies. TRIAL REGISTRATION: Clinical Trials Registry of India (CTRI/2023/02/050027). WHAT'S KNOWN: • Oral 40% dextrose gel is an eff ective fi rst-line treatment for neonatal hypoglycemia and has been shown to reduce treatment failure and intravenous glucose use in previous trials. • Existing evidence is predominantly from high-income settings, with limited randomized data from low- and middle-income countries assessing pragmatic outcomes such as NICU admission. WHAT IS NEW: • In this open-label randomized controlled trial, oral dextrose gel was associated with fewer NICU admissions for hypoglycemia (4.2% vs 12.2%) and higher exclusive breastfeeding rates at discharge and 6 weeks compared with standard care. • These fi ndings support the potential utility of dextrose gel as a simple, low-cost intervention for managing neonatal hypoglycemia in resource-limited settings.