PROSpect
Research type
Research Study
Full title
PRone and OScillation PEdiatric Clinical Trial
IRAS ID
247006
Contact name
Martha A.Q. Curley
Contact email
Sponsor organisation
University of Pennsylvania
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, months, days
Research summary
The question being asked is whether, in children with severe respiratory (breathing) distress syndrome requiring mechanical ventilation (the use of a breathing machine); \n\nBeing nursed in the prone position (on their tummy) alone or in combination with high frequency oscillatory ventilation (HFOV – which is a breathing machine that uses much higher breath rates than conventional ventilators) can reduce the total time these children need to spend on a breathing machine.\n\nIf the answer is yes then this could advantage children by reducing the burden of disease, improving survival and reducing the time spent in hospital. This will be of benefit to both children and parents and in addition could reduce health care costs by shortening hospital stay.\n\nThis is a study of children with paediatric acute respiratory distress syndrome (PARDS) who have severe lung injury, require support on a breathing machine in a children’s intensive care unit and in whom the observed mortality is up to 35%.\n\nChildren with severe PARDS, who are on a breathing machine in intensive care will be eligible. The intensive care units chosen for this study are in the USA, Europe, Asia, Australia, Canada and the UK. All of the units have extensive experience of both prone positioning and the use of HFOV.\n\nThe study for each child will last for 28 days or until they are taken of the breathing machine, whichever is the shorter. There is no follow up for UK participants. All children will undergo routine care but will be randomly allocated to 4 equal groups receiving conventional or high frequency ventilation combined with either supine (on their back) or prone (on their tummy) positioning. Some additional but low volume blood sampling will occur in addition to usual care through indwelling venous or arterial catheters.\n
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
20/YH/0022
Date of REC Opinion
28 Feb 2020
REC opinion
Further Information Favourable Opinion