At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 50 enrolled

Drug / intervention

Xenon gas +1 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02071394

NCT02071394Phase 2Completed

Compare CT.gov

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

University Hospitals Bristol and Weston NHS Foundation Trust·interventional·Posted Feb 25, 2014·Updated Jan 5, 2023

In Brief

A Phase 2 clinical trial evaluating Xenon gas and Whole body cooling for Hypoxic Ischaemic Encephalopathy. Completed, enrolled 50 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHypoxic Ischaemic Encephalopathy

CountriesUnited Kingdom

CollaboratorsUniversity of Bristol

Timeline

Phase 2CompletedFinished

2014201520162017201820192020202120222023202420252026

First PostedFeb 2014

Enrollment StartMar 2014

Primary CompletionOct 2019

Study CompletionApr 2020

TodayJul 2026

First PostedFeb 25, 2014

Enrollment StartMar 1, 2014

Primary CompletionOct 7, 2019

Study CompletionApr 15, 2020

TodayJul 2, 2026

Enrollment to primary: 5.6 yearsPosted 12.4 years ago

Interventions

Xenon gasdrug

Inhalation via endotracheal tube of 50% xenon for 18 hours, including during transport for outborn babies, starting within 5 hours after birth.

Whole body coolingother

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.