Professor Andrew Davidson at the University of Melbourne, Royal Children's Hospital and Murdoch Childrens Research Institute.
The trial has enrolled 427 patients at sites in Australia, the US and Italy. The T-REX trial team is pleased to report the following:
- There are currently seven actively recruiting sites in Australia: Royal Children’s Hospital Melbourne; Queensland Children’s Hospital; Sydney Children’s Hospital; Perth Children’s Hospital and The Children’s Hospital at Westmead, Flinders Medical Centre and the Women’s and Children’s Hospital in Adelaide.
- We now have eight active sites in Italy and five sites in the US.
- Recruitment expected to be completed in March 2023.
Study design
Phase III randomised active controlled, parallel group, assessor blinded, multicentre, superiority trial.
Primary outcome
Global cognitive function as assessed by the full scale IQ score of the Wechsler Preschool and Primary School Intelligence Scale assessed at three years of age.
Study population
Infants aged less than 2 years of age scheduled for surgery expected to last two hours or longer.
Sample size
450 patients.
The Australian National Health and Medical Research Council.
ClinicalTrials.gov Identifier: NCT03089905
For further information about this study, please contact the T-REX Project Manager, Suzette Sheppard by email.