Diazoxide for babies with severe or recurrent low blood glucose: The Neonatal Glucose Care Optimisation (NeoGluCO) Study

Phase 2

Completed

• Conditions: eonatal hypoglycaemia; Neonatal hypoglycaemia; Metabolic and Endocrine - Other metabolic disorders; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12620000129987
• Lead Sponsor: iggins Institute, University of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-11
• Study Completion: 2023-04-15
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

Babies are eligible for this study if they are born at >=35 weeks’ gestation and are admitted to a neonatal unit in the first week after birth with recurrent or severe hypoglycaemia, defined by one or more of the following:
•3 or more episodes of hypoglycaemia <2.6 mmol/L in 48 hours
•Blood glucose of 1.2 to <2.0 mmol/L persisting after 2 doses of dextrose gel and feeding in a single episode
•Any episode of hypoglycaemia <1.2 mmol/L.

Exclusion Criteria

Confirmed major congenital malformation or chromosomal disorder
Suspected genetic syndrome associated with hypoglycaemia, e.g., Beckwith Wiedemann Syndrome
Gastrointestinal disorder likely to affect feed tolerance
Planned or likely neonatal surgery
Confirmed sepsis (culture of pathogenic organism from blood, CSF or urine)
Hypoxic ischaemic encephalopathy
Family history of congenital hyperinsulinism
Suspected inborn error of metabolism
Triplets

Study & Design

• Study Type: Interventional
• Study Design: Not specified