Neuroprotective Effects of Hypothermia Combined With Inhaled Xenon Following Perinatal Asphyxia
Summary
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.
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.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Conditions
Hypoxic Ischaemic Encephalopathy
Intervention
Xenon gas
Location
Imperial College Academic Healthcare Trust
London
United Kingdom
W12 0HS
Status
Recruiting
Source
Imperial College London
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00934700
- Information obtained from ClinicalTrials.gov on May 22, 2012
Medical and Biotech [MESH] Definitions
Xenon Isotopes
Stable xenon atoms that have the same atomic number as the element xenon, but differ in atomic weight. Xe-124, 126, 128-131, 134, and 136 are stable xenon isotopes.
Xenon Radioisotopes
Unstable isotopes of xenon that decay or disintegrate emitting radiation. Xe atoms with atomic weights 121-123, 125, 127, 133, 135, 137-145 are radioactive xenon isotopes.
Misonidazole
A nitroimidazole that sensitizes normally radio-resistant hypoxic cells to radiation. It may also be directly cytotoxic to hypoxic cells and has been proposed as an antineoplastic.
Encephalopathy, Bovine Spongiform
A transmissible spongiform encephalopathy of cattle associated with abnormal prion proteins in the brain. Affected animals develop excitability and salivation followed by ATAXIA. This disorder has been associated with consumption of SCRAPIE infected ruminant derived protein. This condition may be transmitted to humans, where it is referred to as variant or new variant CREUTZFELDT-JAKOB SYNDROME. (Vet Rec 1998 Jul 25;143(41):101-5)
Creutzfeldt-jakob Syndrome
A rare transmissible encephalopathy most prevalent between the ages of 50 and 70 years. Affected individuals may present with sleep disturbances, personality changes, ATAXIA; APHASIA, visual loss, weakness, muscle atrophy, MYOCLONUS, progressive dementia, and death within one year of disease onset. A familial form exhibiting autosomal dominant inheritance and a new variant CJD (potentially associated with ENCEPHALOPATHY, BOVINE SPONGIFORM) have been described. Pathological features include prominent cerebellar and cerebral cortical spongiform degeneration and the presence of PRIONS. (From N Engl J Med, 1998 Dec 31;339(27))
Clinical Trials
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PubMed Articles
Therapeutic hypothermia for newborn infants with hypoxic-ischaemic encephalopathy.
Peripartum asphyxia complicated by moderate or severe hypoxic-ischaemic encephalopathy is a devastating global health issue. A therapeutic 'window of opportunity' exists after resuscitation of the asp...
Video-EEG monitoring in newborns with hypoxic-ischemic encephalopathy treated with hypothermia.
Therapeutic hypothermia (TH) is becoming standard of care in newborns with hypoxic-ischemic encephalopathy (HIE). The prognostic value of the EEG and the incidence of seizures during TH are uncertain.
PURPOSE: To assess the effect of 18 hour (h) 50% xenon (Xe) inhalation at normothermia (NT, 38.5°C) or hypothermia (HT, 33.5°C) on mean arterial blood pressure (MABP), inotrop...
Hyponatremic Encephalopathy Mimicking Hypoxic-Ischemic Encephalopathy.
