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出境医 / 临床实验 / Outcome After 24 Months of Participants in the TOBY Xenon Study

Outcome After 24 Months of Participants in the TOBY Xenon Study

Study Description
Brief 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.


Condition or disease Intervention/treatment
Perinatal Asphyxia Encephalopathy Drug: Xenon

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 69 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neurological Outcome After 24 Months of Age Following Treatment With Xenon Combined With Moderate Hypothermia After Perinatal Asphyxia
Actual Study Start Date : August 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : May 2018
Arms and Interventions
Group/Cohort Intervention/treatment
Standard care with moderate hypothermia
Surviving children allocated to standard care with moderate hypothermia in the TOBY-Xe trial
30% Xenon for 24 hours combined with moderate hypothermia
Surviving children allocated to inhaled xenon combined with moderate hypothermia in the TOBY-Xe trial
 Drug: Xenon
Inhaled xenon gas given via purposely designed ventilator
Other Name: Lenoxe
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 3 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The study population were the surviving participants in the TOBY Xenon study. There were 69 survivors from 92 participants at 2 years after birth and 62 of the 69 participants entered the TOBY Xenon Follow-up Study
Criteria

Inclusion Criteria:

Surviving participants in the TOBY Xenon study

Exclusion Criteria:

Lack of consent to participate

Contacts and Locations

Locations
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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, United Kingdom
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Investigators
Layout table for investigator information
Principal Investigator: David A Edwards, FMedSci King's College London
Tracking Information
First Submitted Date May 14, 2019
First Posted Date May 30, 2019
Last Update Posted Date May 30, 2019
Actual Study Start Date August 2014
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 28, 2019)
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 28, 2019) 		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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 28, 2019)
  • 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
  • Gross Motor Function Classification System [ Time Frame: At 2-3 years of age ]
    Levels 1-5 with higher levels indicating worse neuromotor function
  • Manual Ability Classification System [ Time Frame: At 2-3 years of age ]
    Levels 1-5 with higher levels indicating increasing difficulty in handling objects
  • Clinical signs of cerebral palsy [ Time Frame: At 2-3 years of age ]
    Defined according to Surveillance of Cerebral Palsy in Europe classification.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Outcome After 24 Months of Participants in the TOBY Xenon Study
Official Title Neurological Outcome After 24 Months of Age Following Treatment With Xenon Combined With Moderate Hypothermia After Perinatal Asphyxia
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The study population were the surviving participants in the TOBY Xenon study. There were 69 survivors from 92 participants at 2 years after birth and 62 of the 69 participants entered the TOBY Xenon Follow-up Study
Condition
  • Perinatal Asphyxia
  • Encephalopathy
Intervention Drug: Xenon
Inhaled xenon gas given via purposely designed ventilator
Other Name: Lenoxe
Study Groups/Cohorts
  • Standard care with moderate hypothermia
    Surviving children allocated to standard care with moderate hypothermia in the TOBY-Xe trial
  • 30% Xenon for 24 hours combined with moderate hypothermia
    Surviving children allocated to inhaled xenon combined with moderate hypothermia in the TOBY-Xe trial
    Intervention: Drug: Xenon
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 28, 2019) 		69
Original Actual Enrollment Same as current
Actual Study Completion Date May 2018
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Surviving participants in the TOBY Xenon study

Exclusion Criteria:

Lack of consent to participate
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 3 Years   (Child)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03968861
Other Study ID Numbers IRAS157755
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Guy's and St Thomas' NHS Foundation Trust
Study Sponsor Guy's and St Thomas' NHS Foundation Trust
Collaborators Not Provided
Investigators
Principal Investigator: David A Edwards, FMedSci King's College London
PRS Account Guy's and St Thomas' NHS Foundation Trust
Verification Date May 2019

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