The TOBY Xe Trial version 001
Research type
Research Study
Full title
Neuroprotective effects of hypothermia combined with inhaled xenon following perinatal asphyxia - the TOBY Xe trial
IRAS ID
28415
Contact name
Denis Azzopardi
Sponsor organisation
Imperial College London
Eudract number
2009-014344-11
ISRCTN Number
08886155
Clinicaltrials.gov Identifier
Research summary
This will be a randomised controlled trial of 130 infants with perinatal asphyxial encephalopathy admitted to Queen Charlotte and Chelsea Hospital (QCCH) and University College London Hospital (UCLH), and St Thomas Hospital, London UK. Following informed parental consent, infants with moderate or severe encephalopathy with depressed electrical cortical activity that continue to require endotracheal tube ventilation following resuscitation will be randomised to treatment with hypothermia only or hypothermia and xenon. All infants in both groups will be treated with hypothermia for 72 hours started within 6 hours of delivery and infants allocated to hypothermia and xenon will also receive 30% xenon (balanced with oxygen and air) for 24 hours through a purpose designed delivery system. Clinical signs will be monitored continuously to confirm safety. Structured neurological examination will be done daily during the 1st week after birth and at discharge. The main outcome of the study will be changes on magnetic Resonance studies performed once between 5-14 days of age.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
10/H0707/33
Date of REC Opinion
2 Jun 2010
REC opinion
Further Information Favourable Opinion