None listed
Conditions
Brief summary
The Neonatal Glucose Care Optimisation (NeoGluCO) Study is investigating if early treatment of severe or recurrent neonatal hypoglycaemia (low blood glucose) with oral diazoxide reduces the time to resolution of hypoglycaemia, this is defined as achieving glucose stability (blood glucose in the target range of 2.6 to 5.4 mmol/L), full enteral bolus feeds, and stopping of intravenous fluids. We hypothesise that early diazoxide therapy will improve glycaemic stability, allowing earlier weaning of intravenous fluids and establishment of full feeds. If effective, such a treatment could have major benefits for neonates with severe or recurrent hypoglycaemia, including reduced length of admission and separation of mother and baby, reduced use of formula and facilitation of earlier establishment of breastfeeding, reduced number of heel pricks for blood glucose testing, and better long-term neurodevelopmental outcome.
Interventions
Diazoxide 10 mg/ml as clear suspension. Babies will be loaded with 0.5 ml/kg (diazoxide 5 mg/kg) orally or by gastric tube and then commenced on a maintenance dose of 0.15 ml/kg (diazoxide 1.5 mg/kg) every 12 hours. The study intervention will be prescribed on hospital charts and administered by nurses or midwives. It will be weaned by protocol with the aim of maintaining glucose concentration from 2.6 to 5.4 mmol/L and weaning intravenous dextrose and commencing enteral feeding as soon as possi
Diazoxide 10 mg/ml as clear suspension. Babies will be loaded with 0.5 ml/kg (diazoxide 5 mg/kg) orally or by gastric tube and then commenced on a maintenance dose of 0.15 ml/kg (diazoxide 1.5 mg/kg) every 12 hours. The study intervention will be prescribed on hospital charts and administered by nurses or midwives. It will be weaned by protocol with the aim of maintaining glucose concentration from 2.6 to 5.4 mmol/L and weaning intravenous dextrose and commencing enteral feeding as soon as possible. If glucose concentration is =<2.5, dose will increase to 0.25 ml/kg; if 5.5 to 6.9, dose will be withheld; if 7.0 or more the intervention will be stopped. Weekly dose adjustment for weight will be made, if required, once the baby returns to birthweight. The intervention will continue until the primary outcome is reached, up to a maximum of four weeks.
Sponsors
Liggins Institute, University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
No minimum to 7 Days
Healthy volunteers
No
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
Outcome results
None listed