Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 7, 2009
First Posted Date  ICMJE July 8, 2009
Last Update Posted Date October 28, 2014
Study Start Date  ICMJE February 2012
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2009)
Clinical outcomes at hospital discharge [ Time Frame: At discharge from hospital ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neuroprotective Effects of Hypothermia Combined With Inhaled Xenon Following Perinatal Asphyxia
Official Title  ICMJE Neuroprotective Effects of Hypothermia Combined With Inhaled Xenon Following Perinatal Asphyxia
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypoxic Ischaemic Encephalopathy
Intervention  ICMJE Other: Xenon gas
30% Xenon gas inhaled for 24 hours
Other Name: LENOXe
Study Arms  ICMJE
  • Experimental: Combination of hypothermia and xenon
    Combination of hypothermia and inhaled xenon
    Intervention: Other: Xenon gas
  • No Intervention: Hypothermia and standard intensive care
    Hypothermia and standard intensive care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 27, 2014)
92
Original Estimated Enrollment  ICMJE
 (submitted: July 7, 2009)
130
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 12 Hours   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00934700
Other Study ID Numbers  ICMJE prot-002-2009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Imperial College London
Study Sponsor  ICMJE Imperial College London
Collaborators  ICMJE
  • University College London Hospitals
  • Guy's and St Thomas' NHS Foundation Trust
Investigators  ICMJE
Principal Investigator: Denis Azzopardi, MD Imperial College London
PRS Account Imperial College London
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP