europrotective effects of hypothermia combined with inhaled xenon following perinatal asphyxia - the TOBY Xe trial - The TOBY Xe Trial version 001

Phase 1

• Conditions: eonatal asphyxial encephalopathy; MedDRA version: 12 Level: SOC Classification code 10028946 Term: neonatal hypoxia and asphyxia

• Registration Number: EUCTR2009-014344-11-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-17
• Study Completion: 2014-09-30
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 92

Inclusion Criteria

A Infants 36 to 43 weeks gestation with at least one of the following:
(a) Apgar score of < or =5 at 10 minutes after birth;
(b) Continued need for resuscitation, including endotracheal or mask ventilation, at 10 minutes after birth;
(c) 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).
B 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.
C At least 30 minutes duration of amplitude integrated EEG (aEEG) recording that shows moderately abnormal or suppressed background aEEG activity or seizures.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified