Neuroprotective Effects of Hypothermia Combined With Inhaled Xenon Following Perinatal Asphyxia (TOBYXe)
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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 Endpoint Classification: Safety/Efficacy Study 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 |
- 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 ] [ Designated as safety issue: No ]
- Clinical outcomes at hospital discharge [ Time Frame: At discharge from hospital ] [ Designated as safety issue: Yes ]
| 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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00934700
| United Kingdom | |
| Imperial College Academic Healthcare Trust | |
| London, United Kingdom, W12 0HS | |
| Principal Investigator: | Denis Azzopardi, MD | Imperial College London |
More Information
No publications provided by Imperial College London
Additional 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 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Imperial College London:
|
perinatal asphyxia encephalopathy neuroprotection |
Additional relevant MeSH terms:
|
Brain Ischemia Hypoxia, Brain Hypoxia-Ischemia, Brain Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases |
Xenon Anesthetics Anesthetics, General Anesthetics, Inhalation Central Nervous System Agents Central Nervous System Depressants Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015