Randomised trial of neonatal hypoglycaemia prevention with oral dextrose gel (hPOD): study protocol

Abstract

Background: Neonatal hypoglycaemia is common, affecting up to 15 % of newborn babies and 50 % of those with risk factors (preterm, infant of a diabetic, high or low birthweight). Hypoglycaemia can cause brain damage and death, and babies born at risk have an increased risk of developmental delay in later life. Treatment of hypoglycaemia usually involves additional feeding, often with infant formula, and admission to Neonatal Intensive Care for intravenous dextrose. This can be costly and inhibit the establishment of breast feeding. Prevention of neonatal hypoglycaemia would be desirable, but there are currently no strategies, beyond early feeding, for prevention of neonatal hypoglycaemia. Buccal dextrose gel is safe and effective in treatment of hypoglycaemia. The aim of this trial is to determine whether 40 % dextrose gel given to babies at risk prevents neonatal hypoglycaemia and hence reduces admission to Neonatal Intensive Care. Methods/Design: Design: Randomised, multicentre, placebo controlled trial. Inclusion Criteria: Babies at risk of hypoglycaemia (preterm, infant of a diabetic, small or large), less than 1 h old, with no apparent indication for Neonatal Intensive Care Unit admission and mother intends to breastfeed. Trial entry & randomisation: Eligible babies of consenting parents will be allocated by online randomisation to the dextrose gel group or placebo group, using a study number and corresponding trial intervention pack. Study groups: Babies will receive a single dose of 0.5 ml/kg study gel at 1 h after birth; either 40 % dextrose gel (200 mg/kg) or 2 % hydroxymethylcellulose placebo. Gel will be massaged into the buccal mucosal and followed by a breast feed. Primary study outcome: Admission to Neonatal Intensive Care. Sample size: 2,129 babies are required to detect a decrease in admission to Neonatal Intensive Care from 10-6 % (two-sided alpha 0.05, 90 % power, 5 % drop-out rate). Discussion: This study will investigate whether admission to Neonatal Intensive Care can be prevented by prophylactic oral dextrose gel; a simple, cheap and painless intervention that requires no special expertise or equipment and hence is applicable in almost any birth setting. Trial registration: Australian New Zealand Clinical Trials Registry - ACTRN 12614001263684 .