Background: Effective, safe and baby-friendly interventions are needed to prevent transitional neonatal hypoglycemia, and subsequent neonatal unit admission and neurological sequelae. In the pre-hPOD Dosage Study (ACTRN12613000322730), prophylactic dextrose gel reduced the risk of hypoglycaemia and was associated with better motor and cognitive function at 2 and 6-7 years. However, in the larger multi-center hPOD Trial (ACTRN12614001263684), a single dose of dextrose gel did not decrease admissions, and at 2 years did not reduce neurocognitive impairment but was associated with worse developmental scores.
Objective: In the hPOD Trial, determine if prophylactic dextrose gel at 1 h of age improves neurocognitive function at 6-7 years, without adverse effects on health and wellbeing.
Design/methods: Double-blind, placebo controlled trial of 0.2g/kg buccal dextrose gel or placebo at 1 h of age among infants born at 35 weeks and at risk of transitional hypoglycaemia. At 6-7 years, children underwent a comprehensive developmental and health assessment. The primary outcome was neurocognitive impairment, defined as a standard score >1 SD below the normative mean on ≥1 of seven items from the NIH Toolbox.
Results: 532 of 652(82%) eligible children were assessed in the dextrose gel group and 535 of 642(83%) in the placebo group. 75% of children were exposed in utero to maternal diabetes. The proportion with neurocognitive impairment was similar between groups (dextrose gel 59% vs. placebo 57%, adjusted risk difference[aRD] -3%, 95%CI -3%,9%, p=0.36). Of 11 secondary outcomes, children who received dextrose gel vs. placebo were more likely to have emotional-behavioral difficulty on the Strengths and Difficulty Questionnaire (24% vs. 18%, aRD 7%, 95%CI 1%,12%) and low psychosocial function on the Child Health Questionnaire (17% vs. 12%, aRD 6%, 95%CI 1%,10%). Other secondary outcomes were similar between groups.
Conclusions: Administration of a single dose of dextrose gel in at-risk infants after birth to prevent transitional hypoglycaemia, compared to placebo, has little to no effect on the risk of neurocognitive impairment at early school-age, but could have adverse effects on psychological wellbeing. The current evidence does not support the routine use of dextrose gel for the prevention of neonatal transitional hypoglycaemia.