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Updated: Sep 1, 2025
Biochemical Measurement of Neonatal Hypoxia
Published on: August 24, 2011
Oral diazoxide versus placebo for severe or recurrent neonatal hypoglycaemia: Neonatal Glucose Care Optimisation
Don Laing1, Eamon Walsh1, Jane M Alsweiler2,3
1Liggins Institute, The University of Auckland, Auckland, New Zealand.
Insights
Newborns with severe or recurrent low blood sugar (transitional hypoglycemia) may benefit from diazoxide treatment. This randomized trial investigates diazoxide
Area of Science:
- Neonatal Medicine
- Pharmacology
- Clinical Trials
Background:
- Severe or recurrent transitional hypoglycemia in infants is linked to adverse neurological outcomes.
- Novel therapeutic strategies targeting the underlying pathophysiology of hypoglycemia are needed.
- Diazoxide is a potential treatment that reduces insulin secretion from pancreatic beta-cells.
Purpose of the Study:
- To evaluate the efficacy of diazoxide in treating severe or recurrent transitional hypoglycemia in neonates.
- To compare diazoxide treatment against placebo in a randomized, double-blind trial.
Main Methods:
- A Phase IIB, double-blind, randomized trial involving neonates (≥35 weeks gestation) with transitional hypoglycemia.
- Infants received an oral loading dose of diazoxide (5 mg/kg) or placebo, followed by a maintenance dose (1.5 mg/kg every 12 hours).
- Intervention was titrated to target blood glucose concentrations (BGC) of 2.6–5.4 mmol/L; primary outcome was time to resolution of hypoglycemia.
Conclusions:
- The study aims to determine if diazoxide effectively resolves transitional hypoglycemia, offering a new treatment option for affected neonates.
- Findings will be disseminated to clinicians, researchers, and the public through publications and conferences.
Introduction:
Infants with severe or recurrent transitional hypoglycaemia continue to have high rates of adverse neurological outcomes and new treatment approaches are needed that target the underlying pathophysiology. Diazoxide is one such treatment that acts on the pancreatic β-cell in a dose-dependent manner to decrease insulin secretion.
Methods And Analysis:
Phase IIB, double-blind, two-arm, parallel, randomised trial of diazoxide versus placebo in neonates ≥35 weeks' gestation for treatment of severe (blood glucose concentration (BGC)<1.2 mmol/L or BGC 1.2 to <2.0 mmol/L despite two doses of buccal dextrose gel and feeding in a single episode) or recurrent (≥3 episodes <2.6 mmol/L in 48 hours) transitional hypoglycaemia. Infants are loaded with diazoxide 5 mg/kg orally and then commenced on a maintenance dose of 1.5 mg/kg every 12 hours, or an equal volume of placebo. The intervention is titrated from the third maintenance dose by protocol to target BGC in the range of 2.6-5.4 mmol/L. The primary outcome is time to resolution of hypoglycaemia, defined as the first point at which the following criteria are met concurrently for ≥24 hours: no intravenous fluids, enteral bolus feeding and normoglycaemia. Groups will be compared for the primary outcome using Cox's proportional hazard regression analysis, expressed as adjusted HR with a 95% CI.
Ethics And Dissemination:
This trial has been approved by the Health and Disability Ethics Committees of New Zealand (19CEN189). Findings will be disseminated in peer-reviewed journals, to clinicians and researchers at local and international conferences and to the public.
Trial Registration Number:
ACTRN12620000129987.
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