CompletedPhase 4ACTRN12606000270516

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.


Sponsor

Dr Jane Alsweiler

Enrollment

88 participants

Start Date

Jul 18, 2005

Study Type

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

Sex: Both males and femalesMax Age: 30 Weekss

Plain Language Summary

Simplified for easier understanding

This study investigates High blood sugar levels and insulin treatment in preterm babies. The HINT trial. It is open to both men and women, up to age 30. If you are interested, you may need to attend study visits and follow the research team's instructions.

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 aft

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)

New Zealand

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