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Randomised trial of neonatal hypoglycaemia prevention with oral dextrose gel (hPOD): study protocol
Jane E Harding1, Joanne E Hegarty2,3, Caroline A Crowther4
1Liggins Institute, University of Auckland, Auckland, New Zealand. j.harding@auckland.ac.nz.
Insights
Prophylactic buccal dextrose gel may prevent neonatal hypoglycaemia, reducing the need for Neonatal Intensive Care admissions. This simple intervention offers a promising strategy for at-risk newborns.
Area of Science:
- Neonatal care
- Clinical trials
- Endocrinology
Background:
- Neonatal hypoglycaemia affects up to 15% of newborns, with higher incidence in at-risk infants.
- Untreated hypoglycaemia can lead to severe outcomes including brain damage, death, and developmental delays.
- Current treatments involve additional feeding or intravenous dextrose, which can be costly and hinder breastfeeding.
Purpose of the Study:
- To determine if prophylactic 40% dextrose gel prevents neonatal hypoglycaemia in at-risk infants.
- To assess the efficacy of buccal dextrose gel in reducing admissions to Neonatal Intensive Care.
Main Methods:
- A randomized, multicenter, placebo-controlled trial involving 2,129 at-risk newborns.
- Infants received either 40% dextrose gel or placebo gel buccally at 1 hour after birth.
- Primary outcome measured was admission to Neonatal Intensive Care.
Main Results:
- The study aimed to detect a decrease in Neonatal Intensive Care admissions from 10% to 6%.
- Statistical power of 90% and a two-sided alpha of 0.05 were used for sample size calculation.
- A 5% drop-out rate was factored into the required sample size.
Conclusions:
- This study investigates a simple, inexpensive, and painless intervention for preventing neonatal hypoglycaemia.
- Prophylactic buccal dextrose gel has the potential to reduce Neonatal Intensive Care admissions.
- The intervention's ease of use makes it applicable in diverse birth settings.
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.
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.
