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

Phase 1

Completed

• Conditions: Hypoxic Ischaemic Encephalopathy
• Interventions: Drug: xenon gas; Device: Whole body cooling

• Registration Number: NCT01545271
• Lead Sponsor: University Hospitals Bristol and Weston NHS Foundation Trust

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-29
• Study First Submitted QC: 2012-02-29
• Study First Posted: 2012-03-06
• Study Start: 2012-05
• Primary Completion: 2013-10
• Study Completion: 2015-03
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-12
• Last Update Posted: 2022-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
72h cooling + 18h xenon inhalation	xenon gas	Babies in poor condition at birth and referred to our neonatal unit for standard therapy of cooling to 33.5 degree C body temperature will be randomised to receive xenon gas at 50% concentration for 18 hours
72h cooling + 18h xenon inhalation	Whole body cooling	Babies in poor condition at birth and referred to our neonatal unit for standard therapy of cooling to 33.5 degree C body temperature will be randomised to receive xenon gas at 50% concentration for 18 hours
Standard 72 h whole body cooling therapy	Whole body cooling	Whole body cooling therapy to rectal temperature of 33.5 degree Centigrade (standard therapy)

Primary Outcome Measures

Name	Time	Method
Death and moderate or severe disability - Bayley III	at 18 months of age	Bayley Scales of Infant and Toddler Development III (Bayley III) has three domains: cognition, language and motor skills. Each domain is based on a series of examinations of different severity. The lower cut off level is 55 for cognition, 47 for language and 46 for motor. The upper value can be 145. Assessment of hearing and vision: severe hearing loss defined as inability to hear without amplification; severe visual loss defined as being unable to move independently.

Secondary Outcome Measures

Name	Time	Method
Brain MRI	less than 2 weeks of age	Magnetic Resonance Imaging findings at less than 2 weeks of age
Amplitude Integrated Electroencephalogram (aEEG) grading	Before hospital discharge; usually within one week of birth	Number of hours after birth when aEEG voltage has reached a normal or discontinuous normal pattern

Trial Locations

Locations (1)

St Michael's Hospital; 🇬🇧 Bristol, Avon, United Kingdom