Neuroprotective Effects of Hypothermia Combined With Inhaled Xenon Following Perinatal Asphyxia (TOBYXe)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Imperial College London.
Recruitment status was  Recruiting
Sponsor:
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 21, 2013
Last verified: April 2012
  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

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical outcomes at hospital discharge [ Time Frame: At discharge from hospital ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 130
Study Start Date: February 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00934700

Contacts
Contact: Denis Azzopardi, MD +44 (0) 208 383 3326 d.azzopardi@imperial.ac.uk

Locations
United Kingdom
Imperial College Academic Healthcare Trust Recruiting
London, United Kingdom, W12 0HS
Contact: Denis Azzopardi       d.azzopardi@imperial.ac.uk   
Principal Investigator: Denis Azzopardi, MD         
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

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 21, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Imperial College London:
perinatal asphyxia
encephalopathy
neuroprotection

Additional relevant MeSH terms:
Asphyxia
Asphyxia Neonatorum
Brain Ischemia
Hypothermia
Hypoxia-Ischemia, Brain
Body Temperature Changes
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Death
Hypoxia, Brain
Infant, Newborn, Diseases
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Vascular Diseases
Wounds and Injuries
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 October 22, 2014