Dextrose gel for neonatal hypoglycaemia (the Sugar Babies Study): a randomised, double-blind, placebo-controlled trial

• Published in: The Lancet (British edition) Vol. 382; no. 9910; pp. 2077 - 2083
• Main Authors: Harris, Deborah L, PhD, Weston, Philip J, MBChB, Signal, Matthew, BE [Hons], Chase, J Geoffrey, Prof, Harding, Jane E, Prof
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 21.12.2013; Elsevier Limited
• Subjects: Babies; Blood; Blood Glucose - drug effects; Bottle Feeding; Breast Feeding; Clinical medicine; Diabetes; Double-Blind Method; Drug Administration Schedule; Female; Gels; Glucose; Glucose - administration & dosage; Humans; Hypoglycemia - drug therapy; Infant, Newborn; Internal Medicine; Male; Medical research; Mothers; Sweetening Agents - administration & dosage; Treatment Failure; Australia; New Zealand, North I., Auckland; New Zealand, North I., Waikato; New Zealand
• ISSN: 0140-6736; 1474-547X
• DOI: 10.1016/S0140-6736(13)61645-1

Summary 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.