Condition category
Pregnancy and Childbirth
Date applied
03/07/2009
Date assigned
30/07/2009
Last edited
29/12/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review

Trial website

https://www.npeu.ox.ac.uk/toby-xe

Contact information

Type

Scientific

Primary contact

Dr Denis Azzopardi

ORCID ID

Contact details

Department of Paediatrics
Hammersmith House
DuCane Road
London
W12 5HS
United Kingdom

Additional identifiers

EudraCT number

2009-014344-11

ClinicalTrials.gov number

NCT00934700

Protocol/serial number

G0701714; prot-001-2009

Study information

Scientific title

Neuroprotective effects of hypothermia combined with inhaled xenon following perinatal asphyxia: a randomised controlled trial

Acronym

The TOBYxe trial

Study hypothesis

Following perinatal asphyxia treatment with a combination of hypothermia and inhaled xenon preserves cerebral metabolism and structure.

On 31/10/2014 the following changes were made to the trial record:
1. The anticipated start date was changed from 15/09/2009 to 01/02/2012
2. The anticipated end date was changed from 14/09/2012 to 30/09/2014
3. The target number of participants was changed from 130 to 92

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information can be found at: https://www.npeu.ox.ac.uk/downloads/files/toby-xe/consent/TOBY-Xe-PIL-V7-Fax-Version.pdf

Condition

Perinatal asphyxia with hypoxic-ischaemic encephalopathy

Intervention

Infants will be allocated to one of two groups: intensive care and treatment with hypothermia for 72 hours combined with inhaled 30% xenon gas for 24 hours or intensive care with hypothermia for 72 hours. Magnetic resonance spectroscopy (MRS) and magnetic resonance imaging (MRI) will be performed once between 4 - 10 days of age.

Intervention type

Drug

Phase

Not Applicable

Drug names

Xenon

Primary outcome measures

Reduction in Lac/Naa ratio on magnetic resonance spectroscopy or preserved fractional anisotropy diffusion weighted magnetic resonance imaging.

Secondary outcome measures

Measured prior to hospital discharge:
1. Intracranial haemorrhage
2. Persistent hypotension
3. Pulmonary haemorrhage
4. Pulmonary hypertension
5. Prolonged blood coagulation time
6. Culture proven sepsis
7. Necrotising enterocolitis
8. Cardiac arrhythmia
9. Thrombocytopenia
10. Major venous thrombosis
11. Renal failure treated with dialysis
12. Pneumonia
13. Pulmonary airleak
14. Duration of hospitalisation

Overall trial start date

01/02/2012

Overall trial end date

30/09/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Infants will be eligible for enrolment into the trial if each of the following criteria is fulfilled:
1. Infants 36 to 43 weeks gestation (either sex) with at least one of the following:
1.1. Apgar score of less than 5 at 10 minutes after birth
1.2. Continued need for resuscitation, including endotracheal or mask ventilation, at 10 minutes after birth
1.3. Acidosis defined as pH less than 7.00 and/or base deficit x 16 mmol/L in umbilical cord blood sample or any blood sample within 60 minutes of birth (arterial or venous blood)
2. 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 hypoxic-ischaemic encephalopathy (HIE) will be assessed by Thompson encephalopathy score, and modified Sarnat score.
3. At least 30 minutes duration of amplitude integrated EEG (aEEG) recording that shows moderately abnormal or suppressed background aEEG activity or seizures

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

92

Participant exclusion criteria

1. If treatment with hypothermia is delayed beyond 6 hours, or infants are expected to be greater than 12 hours of age at the time of randomisation
2. Infants with ventilatory oxygen requirement greater than 70%
3. Attending clinician considers infant not suitable to participate because of other serious congenital abnormalities, or the infant's condition appears terminal

Recruitment start date

01/02/2012

Recruitment end date

30/09/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Paediatrics
London
W12 5HS
United Kingdom

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

c/o Gary Roper
Hammersmith Campus
DuCane Road
London
W12 5HS
United Kingdom

Sponsor type

University/education

Website

http://www3.imperial.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) (ref: G0701714)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26708675

Publication citations

Additional files

Editorial Notes

29/12/2015: Publication reference added.