High blood sugar levels and insulin treatment in preterm babies. The HINT trial.
Randomised controlled trial on the effect of tight glycaemic control with insulin in hyperglycaemic very low birth weight (VLBW) preterm neonates on growth.
Dr Jane Alsweiler
88 participants
Jul 18, 2005
Interventional
Conditions
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.
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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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.
Locations(1)
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ACTRN12606000270516