Feasibility study of adding xenon to cooling therapy in neonates

• Research type

  Research Study

• Full title

  A feasibility study of adding xenon to cooling therapy in babies at high risk of brain injury following poor condition at birth

• IRAS ID

  23218

• Contact name

  Marianne Thoresen

• Sponsor organisation

  University Hospital Bristol NHS Foundation Trust

• Eudract number

  2009-014260-19

• Research summary

  This is a first clinical feasibility study of inhaled xenon gas used in the treatment of newborn infants with hypoxic-ischemic encephalopathy (HIE), in combination with cooling, the standard treatment for this condition. Xenon, a rare anaesthetic gas, is almost side-effect free and shows great promise as a method of enhancing the neuroprotection offered by cooling. It is, however, extremely expensive at œ25-50/L. HIE is a major cause of severe cognitive and motor disability in term infants. Until 2005, there was no effective treatment for HIE. Since 1993 we have developed moderate hypothermia (HT) as a neuroprotective treatment culminating in a successful clinical feasibility study in Bristol 1998-9 (10 infants). This experimental work led to the ??CoolCap? trial followed by the UK ??TOBY? trial. In both trials Bristol was a major recruiting centre (PI:MT). The trials have shown that HT significantly reduced disability and cooling has now become standard treatment. Because the protection from HT is only partial (35%), enhancing its effectiveness is desirable. Since 2003 we have demonstrated that xenon and hypothermia in combination, increase cerebral protection to 70% in new-born rats and pigs. We propose to study 12 full term infants with moderate or severe HIE who, on clinical grounds, require mechanical ventilation and hypothermia for 72 hours. Additionally, within 18 hours of birth, xenon will be given in the breathing gas mixture via a special delivery system situated between the ventilator and airway of the infant. This device has been specifically developed to eliminate xenon wastage, without which this putative therapy would be completely unfeasible on cost grounds. The dose and duration of xenon application will be increased in a staged manner as the first 4 infants are enrolled, culminating in 50% xenon for 12 hours in the remaining 8, with frequent monitoring/safety review group meetings during enrolment of infants.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  09/H0106/64

• Date of REC Opinion

  17 Sep 2009

• REC opinion

  Further Information Favourable Opinion