PERINATAL TRIALS REPORT

PT0544

Randomised controlled trial of tight glycaemic control with insulin in hyperglcaemic VLBW and preterm neonates

Plain Language Summary:     Hyperglycaemia is common in Very Low Birthweight (VLBW) and preterm babies. Currently the treatment of hyperglycaemia in preterm babies varies between different neonatal units. In diabetic adults, and critically ill adults there is evidence that treating hyperglycaemia with insulin to maintain strict glcaemic control improves mortality and morbidity. This trial will randomise VLBW and preterm babies with hyperglycaemia to either tight glycaemic control with insulin to maintain the blood glucose at 4-6 mmol/l or less strict control to keep blood glucose 8-10 mmol/l. The primary outcome is growth. The trial is designed as a pilot for a large multi-centre trial with an outcome of mortality and neurodevelopmental outcome.

Trial status:                         Open to accrual

Date trial opened to accrual: August 2005

Trial Objective:

To determine if strict glycaemic control with insulin in hyperglycaemic VLBW and preterm neonates will increase growth and decrease morbidity.

Type of administration:        Single centre

Prinicipal Investigator/s:     

Dr Jane Alsweiler

Ph 09 3670000 ext 2536

Email jalsweiler@adhb.govt.nz

Dr Frank Bloomfield

Ph 027 429 3264

Email f.bloomfield@auckland.ac.nz

Contact Person/s:            

Dr Jane Alsweiler

As above

© IMPACT/PSANZ 2001