NCT02071394

Xenon and Cooling Therapy in Babies at High Risk of Brain Injury Following Poor Condition at Birth

Xenon and Cooling Therapy in Babies at High Risk of Brain Injury Following Poor Condition at Birth: A Randomised Pilot Outcomes Study (COOLXENON3 Study)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University Hospitals Bristol and Weston NHS Foundation Trust · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study examines the effect of inhaled xenon gas 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 + cooling combination will produce better neuroprotection than the standard treatment of cooling alone.

Conditions

• Hypoxic Ischaemic Encephalopathy

Interventions

Type	Name	Description
DRUG	Xenon gas	Inhalation via endotracheal tube of 50% xenon for 18 hours, including during transport for outborn babies, starting within 5 hours after birth.
OTHER	Whole body cooling	Cooling of baby to reduce rectal temperature to 33.5 degree Centigrade(standard treatment), including during transport for outborn babies, starting within 3 hours after birth.

Timeline

• Start date: 2014-03-01
• Primary completion: 2019-10-07
• Completion: 2020-04-15
• First posted: 2014-02-25
• Last updated: 2023-01-05

Locations

2 sites across 1 country: United Kingdom