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

Phase 4

Recruiting

• Conditions: Hypoglycaemia; Infant of diabetic mother; Reproductive Health and Childbirth - Complications of newborn; Metabolic and Endocrine - Other metabolic disorders

• Registration Number: ACTRN12617001473358
• Lead Sponsor: Dr Lydia Kennedy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-18
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

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/

Exclusion Criteria

Major congenital abnormalities

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment failure in allocated study arm defined as:<br>•requirement for continuous intravenous glucose infusion with >10% glucose to maintain blood glucose measurement more than or equal to 3.5mmol/l <br>•and/or failure to obtain central venous access if required<br>•and/or additional therapies (Diazoxide/Glucagon) required<br><br>All blood glucose concentrations will be analysed by the gold standard glucose oxidase method by a combined metabolite/ blood gas analyser (e.g. ABL 700, Radiometer Ltd, Copenhagen, Denmark).[within 48 hours of treatment commencement.]

Secondary Outcome Measures

Name	Time	Method
Cost effectiveness of each treatment. A health economist will assess this outcome based on such measures as length of nursery stay, duration of treatment and relative cost of treatments.[2 weeks];Duration of use of peripheral central venous catheter for glucose administration<br>[1 week after commencement of treatment];Change in weight<br>[24 hours after treatment commencement];Number of hypoglycaemic episodes (defined as a BGL of less than 3.5mmol/l)<br>[within 48 hours of treatment commencement];Length of stay in the nursery[Within 1 week of treatment commencement];Proportion of participants with a reduction in serum sodium to less than 132 mmol/L[In the first 24 hours after commencement of treatment]