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

Autor:	Laing D; Liggins Institute, The University of Auckland, Auckland, New Zealand., Walsh E; Liggins Institute, The University of Auckland, Auckland, New Zealand., Alsweiler JM; Department of Paediatrics: Child and Youth Health, The University of Auckland, Auckland, New Zealand.; Starship Children's Health, Auckland, New Zealand., Hanning SM; School of Pharmacy, The University of Auckland, Auckland, New Zealand., Meyer MP; Department of Paediatrics: Child and Youth Health, The University of Auckland, Auckland, New Zealand.; Kidz First Neonatal Care, Counties Manukau District Health Board, Auckland, New Zealand., Ardern J; Kidz First Neonatal Care, Counties Manukau District Health Board, Auckland, New Zealand., Cutfield WS; Liggins Institute, The University of Auckland, Auckland, New Zealand.; Starship Children's Health, Auckland, New Zealand., Rogers J; Liggins Institute, The University of Auckland, Auckland, New Zealand., Gamble GD; Liggins Institute, The University of Auckland, Auckland, New Zealand., Chase JG; College of Engineering, University of Canterbury, Christchurch, New Zealand., Harding JE; Liggins Institute, The University of Auckland, Auckland, New Zealand., McKinlay CJ; Department of Paediatrics: Child and Youth Health, The University of Auckland, Auckland, New Zealand c.mckinlay@auckland.ac.nz.; Kidz First Neonatal Care, Counties Manukau District Health Board, Auckland, New Zealand.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2022 Aug 17; Vol. 12 (8), pp. e059452. Date of Electronic Publication: 2022 Aug 17.
DOI:	10.1136/bmjopen-2021-059452
Abstrakt:	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. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu