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Dextrose gel for neonatal hypoglycaemia (the Sugar Babies Study): a randomised, double-blind, placebo-controlled
Deborah L Harris1, Philip J Weston2, Matthew Signal3
1Newborn Intensive Care Unit, Waikato District Health Board, Hamilton, New Zealand; Liggins Institute, University of Auckland, Auckland, New Zealand.
Insights
Dextrose gel effectively treats neonatal hypoglycemia in at-risk infants, reducing treatment failures compared to placebo. This simple intervention offers a promising first-line approach for managing low blood sugar in newborns.
Area of Science:
- Neonatal Medicine
- Pediatric Endocrinology
Background:
- Neonatal hypoglycemia is a common condition and a preventable cause of infant brain damage.
- Limited evidence exists on the efficacy of dextrose gel for treating hypoglycemia in newborns.
Purpose of the Study:
- To assess the effectiveness of dextrose gel compared to feeding alone for reversing neonatal hypoglycemia in at-risk infants.
Main Methods:
- A randomized, double-blind, placebo-controlled trial was conducted with 237 at-risk infants (35-42 weeks gestation, <48 hours old).
- Infants received either 40% dextrose gel (200 mg/kg) or placebo gel, with treatment failure defined as blood glucose <2.6 mmol/L after two attempts.
Main Results:
- Dextrose gel significantly reduced treatment failure compared to placebo (14% vs. 24%, RR 0.57, p=0.04).
- No serious adverse events were reported; three infants in the placebo group had a single low blood glucose reading (0.9 mmol/L).
Conclusions:
- Dextrose gel is an inexpensive and simple first-line treatment for neonatal hypoglycemia in late preterm and term infants.
- Consideration of dextrose gel for managing hypoglycemia in the first 48 hours of life is recommended.
Background:
Neonatal hypoglycaemia is common, and a preventable cause of brain damage. Dextrose gel is used to reverse hypoglycaemia in individuals with diabetes; however, little evidence exists for its use in babies. We aimed to assess whether treatment with dextrose gel was more effective than feeding alone for reversal of neonatal hypoglycaemia in at-risk babies.
Methods:
We undertook a randomised, double-blind, placebo-controlled trial at a tertiary centre in New Zealand between Dec 1, 2008, and Nov 31, 2010. Babies aged 35-42 weeks' gestation, younger than 48-h-old, and at risk of hypoglycaemia were randomly assigned (1:1), via computer-generated blocked randomisation, to 40% dextrose gel 200 mg/kg or placebo gel. Randomisation was stratified by maternal diabetes and birthweight. Group allocation was concealed from clinicians, families, and all study investigators. The primary outcome was treatment failure, defined as a blood glucose concentration of less than 2·6 mmol/L after two treatment attempts. Analysis was by intention to treat. The trial is registered with Australian New Zealand Clinical Trials Registry, number ACTRN12608000623392.
Findings:
Of 514 enrolled babies, 242 (47%) became hypoglycaemic and were randomised. Five babies were randomised in error, leaving 237 for analysis: 118 (50%) in the dextrose group and 119 (50%) in the placebo group. Dextrose gel reduced the frequency of treatment failure compared with placebo (16 [14%] vs 29 [24%]; relative risk 0·57, 95% CI 0·33-0·98; p=0·04). We noted no serious adverse events. Three (3%) babies in the placebo group each had one blood glucose concentration of 0·9 mmol/L. No other adverse events took place.
Interpretation:
Treatment with dextrose gel is inexpensive and simple to administer. Dextrose gel should be considered for first-line treatment to manage hypoglycaemia in late preterm and term babies in the first 48 h after birth.
Funding:
Waikato Medical Research Foundation, the Auckland Medical Research Foundation, the Maurice and Phyllis Paykel Trust, the Health Research Council of New Zealand, and the Rebecca Roberts Scholarship.
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