PERINATAL TRIALS REPORT

PTO367

ICE: Infant Cooling Evaluation Trial

Plain Language Summary: Intrapartum hypoxia affects 3-5 per 1000 livebirths with moderate or severe HIE in 0.5-1 per 1000 live births. Of these between 10-60% die and at least 25% of the survivors have neurodevelopmental sequelae. At the moment there is no specific treatment for infants with hypoxia - ischaemic encephalopathy (HIE). Hypothermia is the most promising new treatment to provide neurological resuce for neonates with HIE. This study will randomise 300 infants with HIE to be cooled to 34 degrees C for 72 hours compared with maintaining body temperature at 37 degrees C.

Trial Status:                    Open To Accrual

Date trial opened to accrual:    1 March 2001

Expected accrual period:          3 years

Trial Objective:

To determine if whole body cooling started soon after birth in infants with hypoxia - ischaemic encephalopathy (HIE) will improve survival free of major sensorineural disability.

Trial Administration:        Multi-centre international

Principal Investigator/s:  Dr Susan Jacobs

                                    Ph 61 3 9344 2000

                                    Email jacobs@cryptic.rch.unimelb.edu.au

                                    Professor Colin Morley

                                    Ph 61 3 9344 2524

                                    Email: colin@morleys.net 

Contact Person/s:          Dr Susan Jacobs

                                    Ph 61 3 9344 2000

                                    Email jacobs@cryptic.rch.unimelb.edu.au

© IMPACT/PSANZ 2001