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Completed

NCT Number: NCT03968861

Outcome After 24 Months of Participants in the TOBY Xenon Study

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.

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Key information

Conditions

Perinatal Asphyxia Brain Diseases Central Nervous System Diseases Encephalopathy Nervous System Diseases

Age range

2 year–3 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Guys and St Thomas NHS Trust, London, United Kingdom

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Surviving participants in the TOBY Xenon study

Exclusion criteria

Lack of consent to participate

Treatment and study plan

Xenon

Drug

Inhaled xenon gas given via purposely designed ventilator

Other names: Lenoxe

Primary outcomes

  1. Scores on Bayley scales of infant and toddler development

    Time frame: at 2-3 years of age

    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

  2. Relation between magnetic resonance markers and neurodevelopmental outcome

    Time frame: at 2-3 years of age

    Peak area Lactate/N Acetyl Aspartate ratio on magnetic resonance spectroscopy and fractional anisotropy on diffusion tensor magnetic resonance imaging

Secondary outcomes

  1. Grade of disability

    Time frame: At 2-3 years of age

    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).

Other outcomes

  1. Optimality Scores on Hammersmith neurological examination

    Time frame: At 2-3 years of age

    Range of score is 0-78 with lower scores indicating more abnormal examination

  2. Gross Motor Function Classification System

    Time frame: At 2-3 years of age

    Levels 1-5 with higher levels indicating worse neuromotor function

  3. Manual Ability Classification System

    Time frame: At 2-3 years of age

    Levels 1-5 with higher levels indicating increasing difficulty in handling objects

  4. Clinical signs of cerebral palsy

    Time frame: At 2-3 years of age

    Defined according to Surveillance of Cerebral Palsy in Europe classification.

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
May 30, 2019
Registry last updated
May 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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