Oral diazoxide versus placebo for severe or recurrent neonatal hypoglycaemia: Neonatal Glucose Care Optimisation (NeoGluCO) study – a randomised controlled trial

Autor: Don Laing, Eamon Walsh, Jane M Alsweiler, Sara M Hanning, Michael P Meyer, Julena Ardern, Wayne S Cutfield, Jenny Rogers, Greg D Gamble, J Geoffrey Chase, Jane E Harding, Christopher JD McKinlay
Rok vydání: 2022
Předmět:
Zdroj: BMJ Open. 12:e059452
ISSN: 2044-6055
DOI: 10.1136/bmjopen-2021-059452
Popis: IntroductionInfants 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 analysisPhase 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)Ethics and disseminationThis 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 numberACTRN12620000129987.
Databáze: OpenAIRE