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

This study has been completed.
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 27, 2014
Last verified: April 2012

July 7, 2009
October 27, 2014
February 2012
September 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00934700 on ClinicalTrials.gov Archive Site
Clinical outcomes at hospital discharge [ Time Frame: At discharge from hospital ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Neuroprotective Effects of Hypothermia Combined With Inhaled Xenon Following Perinatal Asphyxia
Neuroprotective Effects of Hypothermia Combined With Inhaled Xenon Following Perinatal Asphyxia

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Hypoxic Ischaemic Encephalopathy
Other: Xenon gas
30% Xenon gas inhaled for 24 hours
Other Name: LENOXe
  • 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
Shankaran S. Outcomes of hypoxic-ischemic encephalopathy in neonates treated with hypothermia. Clin Perinatol. 2014 Mar;41(1):149-59. doi: 10.1016/j.clp.2013.10.008.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
92
September 2014
September 2014   (final data collection date for primary outcome measure)

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.
Both
up to 12 Hours
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00934700
prot-002-2009
Yes
Imperial College London
Imperial College London
  • University College London Hospitals
  • Guy's and St Thomas' NHS Foundation Trust
Principal Investigator: Denis Azzopardi, MD Imperial College London
Imperial College London
April 2012

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