None listed
Conditions
Brief summary
Many very preterm and small babies develop high blood sugar levels in the first few days to weeks after birth. Recent studies in critically ill adults with high blood sugar levels have shown that treatment with insulin to keep blood sugar levels in the normal range improved survival and reduced complications, regardless of whether the patients were diabetic or not. However, we do not know if the same is true for preterm babies. The purpose of this study is therefore to find out if babies with high blood sugar levels do better if their blood sugar level is kept in the normal range (4-6 mmol/l) with insulin treatment compared with the current practice of aiming for a blood sugar level less than 10 mmol/l. This study is a pilot study to determine if treatment is feasible in the newborn and improves growth. If successful, this would lead to a multi centre trial to determine if this treatment decreases mortality or improves neurodevelopmental outcome at 2 years of age.
Interventions
Continuous intravenous insulin infusion starting at 0.05 units/kg.hour, titrated to maintain target blood glucose levels. In the intervention group insulin will be started in hyperglycaemic babies after two concecutive blood glucose levels of > 8.5 mmol/l, 4 hours apart. The insulin will be titrated to maintain the blood glucose level from 4-6 mmol/l.
Sponsors
Dr Jane Alsweiler
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 30 Weeks
Healthy volunteers
No
Inclusion criteria
Babies <30 weeks gestation or <1500g and 2 consecutive blood glucose measurements of >8.5 mmol/l, 4 hours apart.
Exclusion criteria
Hyperglycemia secondary to an accidental overdose. Babies with major congenital malformation. Imminent death
Outcome results
None listed