Professor Andrew Davidson at the University of Melbourne, Royal Children's Hospital and Murdoch Childrens Research Institute.
The trial has completed enrolment of 450 patients at sites in Australia, the US and Italy. The T-REX trial team is pleased to report the following:
- There were 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.
- There were eight active sites in Italy and five sites in the US.
Phase III randomised active controlled, parallel group, assessor blinded, multicentre, superiority trial.
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.
Infants aged less than 2 years of age scheduled for surgery expected to last two hours or longer.
The Australian National Health and Medical Research Council.
2022 IARS SmartTots Research Award (US)
Szmuk P, Andropoulos D, McGowan F, Brambrink A, Lee C, Lee KJ, McCann ME, Liu Y, Saynhalath R, Bong CL, Anderson BJ, Berde C, De Graaff JC, Disma N, Kurth D, Loepke A, Orser B, Sessler DI, Skowno JJ, von Ungern-Sternberg BS, Vutskits L, Davidson A. An open label pilot study of a dexmedetomidine-remifentanil-caudal anesthetic for infant lower abdominal/lower extremity surgery: The T REX pilot study. Paediatr Anaesth. 2019 Jan;29(1):59-67. doi: 10.1111/pan.13544.
ClinicalTrials.gov Identifier: NCT03089905
For further information about this study, please contact the T-REX Project Manager, Suzette Sheppard by email.