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

NCT01545271 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-12-15

No results posted yet for this study

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

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.

DEVICE

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.

Sponsors & Collaborators

  • University of Bristol

    collaborator OTHER

  • University Hospitals Bristol and Weston NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Marianne Thoresen, Professor · University of Bristol

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-10-31
Completion
2015-03-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01545271 on ClinicalTrials.gov