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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
Sponsor:
Collaborators:
University College London Hospitals
Guy's and St Thomas' NHS Foundation Trust
Information provided by (Responsible Party):
Imperial College London

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Hypoxic Ischaemic Encephalopathy Other: Xenon gas Phase 1 Phase 2

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.

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia
Drug Information available for: Xenon
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Clinical outcomes at hospital discharge [ Time Frame: At discharge from hospital ]

Eligibility Criteria
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Information from the National Library of Medicine

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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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: July 8, 2009    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: April 2012

Keywords provided by Imperial College London:
perinatal asphyxia
encephalopathy
neuroprotection

Additional relevant MeSH terms:
Hypothermia
Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Asphyxia
Asphyxia Neonatorum
Body Temperature Changes
Signs and Symptoms
Central Nervous System Diseases
Nervous System Diseases
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
 Hypoxia, Brain
Death
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases
Xenon
Neuroprotective Agents
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Protective Agents