Neuroprotective Effects of Hypothermia Combined With Inhaled Xenon Following Perinatal Asphyxia (TOBYXe)
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ClinicalTrials.gov Identifier: NCT00934700 |
Recruitment Status :
Completed
First Posted : July 8, 2009
Last Update Posted : October 28, 2014
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Condition or disease | Intervention/treatment | Phase |
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Hypoxic Ischaemic Encephalopathy | Other: Xenon gas | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 92 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Neuroprotective Effects of Hypothermia Combined With Inhaled Xenon Following Perinatal Asphyxia |
Study Start Date : | February 2012 |
Actual Primary Completion Date : | September 2014 |
Actual Study Completion Date : | September 2014 |

Arm | Intervention/treatment |
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Experimental: Combination of hypothermia and xenon
Combination of hypothermia and inhaled xenon
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Other: Xenon gas
30% Xenon gas inhaled for 24 hours
Other Name: LENOXe |
No Intervention: Hypothermia and standard intensive care
Hypothermia and standard intensive care
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- The primary outcome will be: reduction in Lac/NAA ratio on magnetic resonance spectroscopy or preserved fractional anisotropy measured on diffusion weighted magnetic resonance imaging [ Time Frame: 10 days ]
- Clinical outcomes at hospital discharge [ Time Frame: At discharge from hospital ]

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Ages Eligible for Study: | up to 12 Hours (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Infants will be eligible for enrolment into the trial if each of the following criteria is fulfilled:
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Infants 36 to 43 weeks gestation with at least one of the following:
- Apgar score of <5 at 10 minutes after birth;
- Continued need for resuscitation, including endotracheal or mask ventilation, at 10 minutes after birth;
- Acidosis defined as pH <7.00 and/or base deficit >15 mmol/L in umbilical cord blood sample or any blood sample within 60 minutes of birth (arterial or venous blood).
- Moderate to severe encephalopathy consisting of altered state of consciousness (reduced or absent response to stimulation) and hypotonia, and abnormal primitive reflexes (weak or absent suck or Moro response). Clinical severity of HIE will be assessed by Thompson encephalopathy score, and modified Sarnat score.
- At least 30 minutes duration of amplitude integrated EEG (aEEG) recording that shows moderately abnormal or suppressed background aEEG activity or seizures
Exclusion Criteria:
- If treatment with hypothermia is delayed beyond 6 hours, or infants are expected to be >12 hours of age at the time of randomisation; Infants with ventilatory oxygen requirement > 70%; Attending clinician considers infant not suitable to participate because of other serious congenital abnormalities, or the infant's condition appears terminal.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00934700
United Kingdom | |
Imperial College Academic Healthcare Trust | |
London, United Kingdom, W12 0HS |
Principal Investigator: | Denis Azzopardi, MD | Imperial College London |
Responsible Party: | Imperial College London |
ClinicalTrials.gov Identifier: | NCT00934700 |
Other Study ID Numbers: |
prot-002-2009 |
First Posted: | July 8, 2009 Key Record Dates |
Last Update Posted: | October 28, 2014 |
Last Verified: | April 2012 |
perinatal asphyxia encephalopathy neuroprotection |
Brain Diseases Brain Ischemia Hypoxia-Ischemia, Brain Hypothermia Asphyxia Central Nervous System Diseases Nervous System Diseases Body Temperature Changes Cerebrovascular Disorders Vascular Diseases Cardiovascular Diseases |
Hypoxia, Brain Death Pathologic Processes Wounds and Injuries Xenon Anesthetics, Inhalation Anesthetics, General Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |