Outcome at 2 Years after Dextrose Gel Treatment for Neonatal Hypoglycemia: Follow-Up of a Randomized Trial

Abstract

Objective To determine neurodevelopmental outcome at two years’ corrected age in children randomized to treatment with dextrose gel or placebo for hypoglycemia soon after birth (The Sugar Babies Study). Study design This was a follow-up study of 184 children who had been hypoglycemic (< 2.6mM [45 mg/dL]) in the first 48 hours and randomized to either dextrose (90/118, 76%) or placebo gel (94/119, 79%). Assessments were performed at Kahikatea House, Hamilton, New Zealand, and included neurological function and general health (Pediatrician assessed), cognitive, language, behaviour and motor skills (Bayley-III), executive function (clinical assessment and BRIEF-P), and vision (clinical examination and global motion perception). Co-primary outcomes were neurosensory impairment (cognitive, language or motor score below −1 SD or cerebral palsy or blind or deaf) and processing difficulty (executive function or global motion perception worse than 1.5 SD from the mean). Statistical tests were two sided with 5% significance level. Results Mean (±SD) birth weight was 3093 ± 803 g and mean gestation was 37.7 ±1.6 weeks. Sixty-six children (36%) had neurosensory impairment (1 severe, 6 moderate, 59 mild) with similar rates in both groups (dextrose 38% vs. placebo 34%, RR 1.11, 95% CI 0.75–1.63). Processing difficulty was also similar between groups (dextrose 10% vs. placebo 18%, RR 0.52, 95% CI 0.23–1.15). Conclusions Dextrose gel is safe for treatment of neonatal hypoglycemia, but neurosensory impairment is common amongst these children.

An emerging evidence base for the management of neonatal hypoglycaemia

“…Recurrent and rebound episodes of hypoglycaemia were uncommon and there was no hyperglycaemia. At follow-up at 2 years of age, dextrose gel appeared safe, with no effects on neurosensory impairment, processing difficulties, or developmental and growth outcomes 20 .…”

Does low body fat percentage in neonates greater than the 5th percentile birthweight increase the risk of hypoglycaemia and neonatal morbidity?

“…Our data suggest that measuring BF% and screening low BF% neonates clearly identifies a significant percentage of hypoglycaemic neonates. Recent studies in New Zealand show progress in the treatment of hypoglycaemic neonates with oral sucrose gel, resulting in fewer neonates requiring intravenous glucose, nursery admission and separation from parents. These neonates also showed no difference in neonatal outcomes at 2 years .…”

“…Recent studies in New Zealand show progress in the treatment of hypoglycaemic neonates with oral sucrose gel, resulting in fewer neonates requiring intravenous glucose, nursery admission and separation from parents. These neonates also showed no difference in neonatal outcomes at 2 years . A policy of screening with BF% and early treatment with sucrose gel has the potential to minimise testing by targeting those neonates most at risk and to keep mothers and babies together, reduce nursery admission and support breastfeeding.…”

Swedish national guideline for prevention and treatment of neonatal hypoglycaemia in newborn infants with gestational age ≥35 weeks

“…It is of importance that the glucose value is related to other existent or non‐existent alternative energy fuels and counter‐regulating hormones . Although there is currently a lack of evidence for a defined cut‐off value, randomised studies provide support for aiming for a plasma glucose level above 2.6 mmol/L after the initial adaptation phase, that is after three hours postnatal age (Figure ) . After completed adaptation process at about 72 hours after birth, plasma glucose should remain steady above 3 mmol/L …”