Trials Sponsors Conditions Drugs Pricing

Conditions

Hypoxic Ischaemic Encephalopathy

Keywords

perinatal asphyxiaencephalopathyneuroprotection

Outcome Measures

Primary Outcomes (2)

Lactate (Lac) / N Acetyl Aspartate (NAA) Ratio on Magnetic Resonance Spectroscopy
Cerebral Lac/NAA ratio measured by magnetic resonance spectroscopy in patents
10 days
Cerebral Fractional Anisotropy Measured by Diffusion Weighted Magnetic Resonance Imaging
Fractional anisotropy (FA) is a measure of tissue integrity in white matter tracts measured by diffusion tensor MRI, and it has been used in work in animals to assess potential neuroprotectants and can be used to predict subsequent neurological outcomes after birth asphyxia, including in infants treated with moderate hypothermia. It is a scalar value between 0-1 that describe anisotropy of a diffusion process. A value of zero means that diffusion is unrestricted (or equally restricted) in all directions. A value of one means that diffusion occurs only along one axis and is fully restricted along all other directions" or similar. Fractional anisotropy data were extracted froma mask of the posterior limb of the internal capsule via tract-based spatial statistics. \*Coefficient of variation=√(exp(var)-1), where var is the variance on the log scale
10 days

Secondary Outcomes (1)

Amiel Tison Evaluation at Hospital Discharge
At discharge from hospital

Study Arms (2)

Combination of hypothermia and xenon

EXPERIMENTAL

Combination of hypothermia and inhaled xenon

Other: Xenon gas

Hypothermia and standard intensive care

NO INTERVENTION

Hypothermia and standard intensive care

Interventions

Xenon gasOther

30% Xenon gas inhaled for 24 hours

Also known as: LENOXe

Combination of hypothermia and xenon

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age1 Hour - 12 Hours

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

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:

Sponsors & Collaborators

University College London Hospitals
Othercollaborator
Guy's and St Thomas' NHS Foundation Trust
Othercollaborator
Imperial College London

Study Sites (1)

Imperial College Academic Healthcare Trust

London, W12 0HS, United Kingdom

Related Publications (2)

Azzopardi D, Robertson NJ, Bainbridge A, Cady E, Charles-Edwards G, Deierl A, Fagiolo G, Franks NP, Griffiths J, Hajnal J, Juszczak E, Kapetanakis B, Linsell L, Maze M, Omar O, Strohm B, Tusor N, Edwards AD. Moderate hypothermia within 6 h of birth plus inhaled xenon versus moderate hypothermia alone after birth asphyxia (TOBY-Xe): a proof-of-concept, open-label, randomised controlled trial. Lancet Neurol. 2016 Feb;15(2):145-153. doi: 10.1016/S1474-4422(15)00347-6. Epub 2015 Dec 19.
PMID: 26708675RESULT
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.
PMID: 24524452DERIVED

MeSH Terms

Conditions

Hypoxia-Ischemia, BrainBrain Diseases

Interventions

Lasers, Gas

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersCentral Nervous System DiseasesNervous System DiseasesHypoxia, BrainVascular DiseasesCardiovascular DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title: Research Integrity Officer
Organization: Imperial College London

Study Officials

Denis Azzopardi, MD
Imperial College London
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

92 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 7, 2009

First Posted

July 8, 2009

Study Start

February 2012

Date type not reported

This date has not been verified as actual or estimated.

Neuroprotective Effects of Hypothermia Combined With Inhaled Xenon Following Perinatal Asphyxia

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (2)

Combination of hypothermia and xenon

Hypothermia and standard intensive care

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (2)

Combination of hypothermia and xenon

Hypothermia and standard intensive care

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations