CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 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/NCT01545271
NCT01545271Phase 2Completed
CompareCT.gov

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

University Hospitals Bristol and Weston NHS Foundation Trust·interventional·Posted Mar 6, 2012·Updated Dec 15, 2022

In Brief

A Phase 2 clinical trial evaluating xenon gas and Whole body cooling for Hypoxic Ischaemic Encephalopathy. Completed, enrolled 32 participants across 1 site.

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
201220132014201520162017201820192020202120222023202420252026
First PostedMar 6, 2012
Enrollment StartMay 1, 2012
Primary CompletionOct 1, 2013
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 14.3 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 coolingdevice

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.