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Neuroprotective Effects of Hypothermia Combined With Inhaled Xenon Following Perinatal Asphyxia (TOBYXe)
This study has been completed.
Sponsor:
Imperial College London
Collaborators:
University College London Hospitals
Guy's and St Thomas' NHS Foundation Trust
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT00934700
First received: July 7, 2009
Last updated: October 27, 2014
Last verified: April 2012
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Purpose
This is a randomised controlled trial in newborn infants with perinatal asphyxial encephalopathy assessing whether a combination of hypothermia and inhaled xenon preserve cerebral metabolism and structure.
| Condition | Intervention | Phase |
|---|---|---|
| Hypoxic Ischaemic Encephalopathy | Other: Xenon gas | Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Neuroprotective Effects of Hypothermia Combined With Inhaled Xenon Following Perinatal Asphyxia |
Resource links provided by NLM:
Further study details as provided by Imperial College London:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- Clinical outcomes at hospital discharge [ Time Frame: At discharge from hospital ]
| Enrollment: | 92 |
| Study Start Date: | February 2012 |
| Study Completion Date: | September 2014 |
| Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Combination of hypothermia and xenon
Combination of hypothermia and inhaled xenon
|
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
|
Detailed Description:
The study hypothesis is that: Following perinatal asphyxia treatment with a combination of hypothermia and inhaled xenon preserves cerebral metabolism and structure. Following informed parental consent, infants that continue to require endotracheal tube ventilation following resuscitation will be randomised to treatment with hypothermia only or hypothermia and xenon. All infants in both groups will be treated with hypothermia for 72 hours started within 6 hours of delivery and infants allocated to hypothermia and xenon will also receive 30% xenon (balanced with oxygen and air) for 24 hours through a purpose designed delivery system. Structured neurological examination will be done daily during the 1st week after birth and at discharge. MRS and MRI will be performed once between 4-10 days of age. MRS/MRI data analysis will be by investigators blinded to the allocated intervention.
Eligibility| Ages Eligible for Study: | up to 12 Hours (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Infants will be eligible for enrolment into the trial if each of the following criteria is fulfilled:
-
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00934700
Please refer to this study by its ClinicalTrials.gov identifier: NCT00934700
Locations
| United Kingdom | |
| Imperial College Academic Healthcare Trust | |
| London, United Kingdom, W12 0HS | |
Sponsors and Collaborators
Imperial College London
University College London Hospitals
Guy's and St Thomas' NHS Foundation Trust
Investigators
| Principal Investigator: | Denis Azzopardi, MD | Imperial College London |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Imperial College London |
| ClinicalTrials.gov Identifier: | NCT00934700 History of Changes |
| Other Study ID Numbers: |
prot-002-2009 |
| Study First Received: | July 7, 2009 |
| Last Updated: | October 27, 2014 |
Keywords provided by Imperial College London:
|
perinatal asphyxia encephalopathy neuroprotection |
Additional relevant MeSH terms:
|
Brain Ischemia Hypoxia-Ischemia, Brain Hypothermia Brain Diseases Asphyxia Neonatorum Asphyxia Cerebrovascular Disorders Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Hypoxia, Brain Body Temperature Changes |
Signs and Symptoms Infant, Newborn, Diseases Death Pathologic Processes Wounds and Injuries Neuroprotective Agents Xenon Protective Agents Physiological Effects of Drugs Anesthetics, Inhalation Anesthetics, General Anesthetics Central Nervous System Depressants |
ClinicalTrials.gov processed this record on June 26, 2017