NCT00934700

Neuroprotective Effects of Hypothermia Combined With Inhaled Xenon Following Perinatal Asphyxia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 1 Hour – 12 Hours
• Healthy volunteers: Not accepted

Summary

This is a randomised controlled trial in newborn infants with perinatal asphyxial encephalopathy assessing whether a combination of hypothermia and inhaled xenon preserve cerebral metabolism and structure.

Detailed description

The study hypothesis is that: Following perinatal asphyxia treatment with a combination of hypothermia and inhaled xenon preserves cerebral metabolism and structure. Following informed parental consent, infants 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. Structured neurological examination will be done daily during the 1st week after birth and at discharge. MRS and MRI will be performed once between 4-10 days of age. MRS/MRI data analysis will be by investigators blinded to the allocated intervention.

Conditions

• Hypoxic Ischaemic Encephalopathy

Interventions

Type	Name	Description
OTHER	Xenon gas	30% Xenon gas inhaled for 24 hours

Timeline

• Start date: 2012-02-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2009-07-08
• Last updated: 2022-04-21
• Results posted: 2022-04-21

Locations

1 site across 1 country: United Kingdom