CoolXenon2 study

• Research type

  Research Study

• Full title

  Xenon and cooling therapy in babies at high risk of brain injury following poor condition at birth: Randomised pilot study. (CoolXenon2 study)

• IRAS ID

  85207

• Contact name

  Marianne Thoresen

• Sponsor organisation

  University Hospital Bristol NHS Foundation Trust

• Eudract number

  2011-005397-34

• Research summary

  The proposed study is planned to be a single centre study at St. Michael??s Hospital Bristol, prospective randomised pilot clinical study. It may include Southmead Hospital Bristol at a later stage if recruitment is low. We have included a shorter delay for recruitment to optimize the effectiveness of hypothermia and potentially xenon. We will accept cooled infants that are < 3h old and start xenon within 5 h of age. In an experimental study we did not find any improvement of adding xenon if both were started at 5 hours after the insult [6], however 2h delayed xenon when HT was started immediately was more effective than HT alone [7]. The study examines the effect of inhaled xenon gas used in the treatment of newborn infants with hypoxic-ischemic encephalopathy (HIE), in combination with cooling which is the standard treatment for this condition. The hypothesis is that the xenon犊▊ combination will produce better neuroprotection than the standard treatment, cooling, alone. 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. We propose to study 24 full term infants with moderate or severe HIE who, on clinical grounds, require mechanical ventilation and hypothermia for 72 hours. The hypothermia (cooling) will be routinely applied if the standard existing criteria for this are met except recruitment needs to be earlier,<3h rather than 6h as noted above. Candidates for the study will be randomly assigned to one of two groups: (i) the standard treatment for this condition, 72 hours of cooling, i.e. the treatment they are already receiving, or (ii) addition of 50% xenon concentration in the breathing gas from the mechanical ventilator for 18 hours in combination with the existing cooling regime, the cooling then continuing to 72 hours. All efforts will be made to commence delivery of the xenon and cooling as soon as possible after birth, with maximum delay of 5 hours for xenon and 3 hours for cooling. 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 [8], without which this putative therapy would be completely unfeasible on cost grounds. It has recently been successfully used in 14 babies with the same entry criteria in our recent MHRA approved human feasibility/safety study [9]. Meetings of an independent Data Review Group will take place after the recruitment of every 4th baby during enrolment of infants to the xenon犊▊ group.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  12/SW/0010

• Date of REC Opinion

  24 Feb 2012

• REC opinion

  Further Information Favourable Opinion