Background The definition of neonatal hypoglycemia is still subject to discussion, resulting in a wide range of treatment protocols.
Objective To compare two expert-based management strategies at both ends of the current treatment-spectrum of ‘moderate’ neonatal hypoglycemia (plasma glucose 2.0–2.5 mmol/l).
Design/methods Otherwise healthy, ‘high-risk’ newborns ≥35 weeks and ≥2000 gram with moderate hypoglycemia: premature, small- or large-for-gestational-age or infants of diabetic mothers, were randomised to an intensive treatment strategy (aiming at [glucose] ≥2.6 mmol/l) or an expectant monitoring strategy (aiming at [glucose] ≥2.0 mmol/l). Development was assessed at 18 months (corrected) age, using the Bayley Scales of Infant Development (BSID-III). The study was designed as a non-inferiority trial.
Results In 84% of the 691 enrolled infants the BSID-III was performed. Cognitive and motor outcomes were comparable in both treatment arms (Table). The results were similar in the overall analysis and in the subgroups.
The plasma glucose concentration was higher in the intensive treatment group: +0.24 mmol/l (+0.31;+0.16). Hypoglycemia episodes (after randomization) occurred more frequently in the expectant monitoring group (70% vs. 57%, p < 0.001). More infants in the intensive treatment group received additional feeding (94% vs. 76%), tube-feeding (12% vs. 4%) and/or intravenous glucose (20% vs. 6%) (all: p < 0.001).
Conclusion An expectant monitoring strategy is not inferior to intensive treatment with regard to developmental outcome at 18 months in otherwise healthy newborn infants ≥35 weeks and ≥2000 gram with moderate hypoglycemia.