627 - School-age outcomes after a randomized trial of dextrose gel to prevent neonatal hypoglycemia

Publication Number: 2612.627

Jane Harding, Liggins Institute, University of Auckland, Auckland, Auckland, New Zealand; Jane M Alsweiler, University of Auckland, Auckland, Auckland, New Zealand; Gavin T. L.. Brown, The University of Auckland, Auckland, Auckland, New Zealand; Gregory D. Gamble, The University of Auckland, Auckland, Auckland, New Zealand; Alicia A. McNeill, The Liggins Institute, University of Auckland, Auckland, Auckland, New Zealand; Jenny Ann. Rogers, Liggins institute, Auckland, Auckland, New Zealand; Benjamin Thompson, University of Waterloo, Waterloo, ON, Canada; Jason Turuwhenua, Auckland University, Auckland, Auckland, New Zealand; Trecia A. Wouldes, University of Auckland, Auckland, Auckland, New Zealand; Christopher JD. McKinlay, University of Auckland, Auckland, Auckland, New Zealand

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 hypoglycemia and was associated with better motor and cognitive function at 2 and 6-7 years of age. However, in the larger multi-center hPOD Trial (ACTRN12614001263684), a single dose of dextrose gel did not decrease neonatal unit admissions, and at 2 years did not reduce neurocognitive impairment but was associated with slightly worse developmental scores. Here we report school-age outcomes from the hPOD Trial.

Objective: To 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: In the double-blind hPOD Trial, infants born at ≥35 weeks, ≥2.2 kg and with one or more risk factors for hypoglycemia (preterm; maternal diabetes; small or large birthweight) were randomized to 0.2 g/kg buccal dextrose gel or placebo at 1 h of age. 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 one or more 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. 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. In meta-analysis of the prehPOD and hPOD trials, any dose of dextrose gel vs. placebo had little to no effect on neurocognitive impairment at 6-7 years (RD -2%, 95%CI -7%, 4%, N=1364).

Conclusion(s): Administration of a single dose of dextrose gel in at-risk infants after birth to prevent transitional hypoglycemia, 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 transitional neonatal hypoglycemia.