Outcome After 24 Months of Participants in the TOBY Xenon Study

Encephalopathy Clinical Trial

Official title:

Neurological Outcome After 24 Months of Age Following Treatment With Xenon Combined With Moderate Hypothermia After Perinatal Asphyxia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03968861
• Other study ID #: IRAS157755
• Status: Completed
• Start date: August 2014
• Est. completion date: May 2018

Study information

• Verified date: May 2019
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this study is to document the outcome at 2-3 years of age of participants of the TOBY Xe trial, to provide preliminary information about the later clinical effects of treatment with Xenon gas combined with moderate hypothermia following perinatal asphyxia. The TOBY Xe trial was a randomised controlled trial of inhaled xenon gas combined with hypothermia for the treatment of perinatal asphyxia. The trial primary outcome was changes on magnetic resonance parameters examined prior to discharge from hospital.

Continuing clinical follow-up of trial participants is important following any therapeutic trial and is essential in early phase trials where information on the clinical effects of the intervention are lacking. Therefore, we have set up this study to determine the major clinical and neurological outcomes of participants of the TOBY Xe trial and to determine whether the magnetic resonance parameters in that trial are qualified to predict outcome following neural rescue therapy. This information is necessary for planning further studies of this intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: May 2018
• Est. primary completion date: June 2017
• Gender: All
• Age group: 2 Years to 3 Years

Eligibility

Inclusion Criteria:

Surviving participants in the TOBY Xenon study

Exclusion Criteria:

Lack of consent to participate

Related Conditions & MeSH terms

• Asphyxia
• Asphyxia Neonatorum
• Brain Diseases
• Encephalopathy
• Perinatal Asphyxia

Intervention

Drug:
• Xenon
Inhaled xenon gas given via purposely designed ventilator

Locations

Country	Name	City	State
United Kingdom	Guys and St Thomas NHS Trust	London
United Kingdom	Imperial College London NHS Healthcare Trust	London
United Kingdom	University College London Hospital NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Optimality Scores on Hammersmith neurological examination	Range of score is 0-78 with lower scores indicating more abnormal examination	At 2-3 years of age
Other	Gross Motor Function Classification System	Levels 1-5 with higher levels indicating worse neuromotor function	At 2-3 years of age
Other	Manual Ability Classification System	Levels 1-5 with higher levels indicating increasing difficulty in handling objects	At 2-3 years of age
Other	Clinical signs of cerebral palsy	Defined according to Surveillance of Cerebral Palsy in Europe classification.	At 2-3 years of age
Primary	Scores on Bayley scales of infant and toddler development	Composite scores of the Cognitive, Language and Motor scales scaled to a metric, with a mean of 100, standard deviation of 15, and range of 40 to 160	at 2-3 years of age
Primary	Relation between magnetic resonance markers and neurodevelopmental outcome	Peak area Lactate/N Acetyl Aspartate ratio on magnetic resonance spectroscopy and fractional anisotropy on diffusion tensor magnetic resonance imaging	at 2-3 years of age
Secondary	Grade of disability	The grade of disability, categorised as mild disability (a Cognitive score of 70 to 84, level 1 gross motor function [is able to walk independently but may have some gait abnormalities], or abnormality in one or both eyes with normal or nearly normal vision), moderate disability (a Cognitive scale score of 56 to 69, level 2 or 3 gross motor function [has minimal ability to perform gross motor skills or requires assistance with walking], or moderately reduced vision), or severe disability (a Cognitive scale score of 55 (the minimum score on the Bayley Cognitive scale), level 4 or 5 gross motor function [needs adaptive seating or has severely limited mobility], or no useful vision).	At 2-3 years of age