None listed
Conditions
Brief 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
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)
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 thi
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.
Sponsors
Dr Lydia Kennedy
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
No minimum to 12 Hours
Healthy volunteers
No
Inclusion criteria
Infants of diabetic mothers (any type of diabetes) who satisfy ALL of the following: 1. more than or equal to 35 weeks gestation 2. Birth-weight more than 2.2 kg 3. Less than 12 hours old 4. Unlikely to require admission to NICU for any other reason e.g. respiratory distress 5. Diagnosis of neonatal hypoglycaemia with 10% Glucose infusion rate 90ml/kg/day and BGL less than 3.5mmol/L
Exclusion criteria
Major congenital abnormalities
Outcome results
None listed