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RecruitingPhase 4ACTRN12617001473358

Treating hypoglycaemia in newborns with Glucagon And Diazoxide: The Glad Study

A randomized, controlled trial to evaluate the effect of Diazoxide and Glucagon for the treatment of significant hypoglycaemia in neonates: The GLAD study

Sponsor

Dr Lydia Kennedy

Enrollment

100 participants

Start Date

Feb 12, 2018

Study Type

Interventional

Conditions

HypoglycaemiaInfant of diabetic mother

Summary

The aim of this research project is to compare Glucagon with Diazoxide for the maintenance of normal blood sugar levels in babies of mothers with diabetes who have low blood sugar levels. The routine nursery treatment differs with each baby but includes use of high concentration sugar infusion (drip) given through an IV line placed in a large vein, intravenous Glucagon and oral Diazoxide. We aim to determine which of these medications, Glucagon or Diazoxide, is better at maintaining blood sugar and which is easier to use

Eligibility

Sex: Both males and femalesMax Age: 12 Hourss

Plain Language Summary

Simplified for easier understanding

This study is for newborn babies born to mothers with diabetes who develop low blood sugar levels (hypoglycaemia) after birth. Researchers want to find out whether Glucagon or Diazoxide is the better medication for keeping a baby's blood sugar at a safe level. You may be eligible if: - The baby was born to a mother with any type of diabetes - The baby is at least 35 weeks gestational age at birth - The baby weighs more than 2.2 kg at birth - The baby is less than 12 hours old - The baby has low blood sugar despite receiving glucose through an IV drip You may NOT be eligible if: - The baby has a major birth defect or congenital abnormality Talk to your doctor about whether this trial might be right for you.

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Interventions

Diazoxide – 5mg/kg/dose 8 hourly orally. Treatment algorithm will be used to maintain treatment fidelity, with increases and decreases in glucose and medications based on blood glucose level (BGL) F

Diazoxide – 5mg/kg/dose 8 hourly orally. Treatment algorithm will be used to maintain treatment fidelity, with increases and decreases in glucose and medications based on blood glucose level (BGL) Fluids or Diazoxide will be titrated down (by 1mg/kg) if BGL is 5.0mmol/L. Treatment will continue until Diazoxide is no longer required; OR if BGLs not maintained at 3.5 mmol/L or more in spite of maximal therapy; OR at 48 hours; OR at discretion of clinician (with reason to be documented). After this point, further management is at the discretion of the clinician and may involve increased concentration glucose infusion or use of glucagon. Adherence with treatment algorithm will be monitored by investigators. The case notes of all enrolled patients will be screened for adherence by research nurse/investigators.

Locations(1)

Womens and Childrens Hospital - North Adelaide

SA, Australia

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ACTRN12617001473358

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