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

History of Changes

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:

MedlinePlus related topics: Brain Diseases Hypothermia

Genetic and Rare Diseases Information Center resources: Asphyxia Neonatorum

U.S. FDA Resources

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 ]


Enrollment:	92
Study Start Date:	February 2012
Study Completion Date:	September 2014
Primary Completion Date:	September 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 (Child)
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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Review.


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 27, 2014
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on September 23, 2016

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