TOBY Xenon 2 year Follow-up Study
Research type
Research Study
Full title
The TOBY Xe study 2 year follow-up: 2 year outcomes following neuroprotective treatment with hypothermia combined with inhaled xenon following perinatal asphyxia
IRAS ID
157755
Contact name
Keith Brennan
Contact email
Sponsor organisation
King’s College London
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The objective of this study is to document the outcome at 2-3 years of age of participants of the TOBY Xe trial, to provide preliminary information about the later clinical effects of treatment with Xenon gas combined with moderate hypothermia following perinatal asphyxia.
The TOBY Xe trial was a randomised controlled trial of inhaled xenon gas combined with hypothermia for the treatment of perinatal asphyxia. Full-term infants up to 43 weeks gestation were randomised within 12 hours of birth to 30% xenon gas given for 24 hours combined with 72 hours of moderate hypothermia or to standard care, which included treatment with 72 hours of hypothermia. Treatment with hypothermia was by a standard protocol and commenced within 6 hours of birth. The trial outcome measures were changes on Magnetic Resonance data and clinical outcomes at discharge from hospital.
Continuing clinical follow-up of trial participants is important following any therapeutic trial and is essential in early phase trials where information on the clinical effects of the intervention are lacking. Therefore, we have set up this study to determine the major clinical and neurological outcomes of participants of the TOBY Xe trial. This information is necessary for planning further studies of this intervention.
The study participants will be the participants of the TOBY Xe study that survived to hospital discharge. The TOBY Xe study was carried out in three London centres: Queen Charlotte and Chelsea Hospital,St Thomas’ Hospital, University College Hospital. Enrollment to the trial started January 2012 and ended September 2014. Approximately half the enrolled infants were referred from other hospitals. 92 infants were recruited and there were 71 survivors at hospital discharge. Children will be assessed at one of the three participating hospitals or at home.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
15/SC/0201
Date of REC Opinion
27 Mar 2015
REC opinion
Favourable Opinion