Perinatal AsphyxiaNCT03968861
Outcome After 24 Months of Participants in the TOBY Xenon Study
An observational study of Perinatal Asphyxia and Encephalopathy, run by Guy's and St Thomas' NHS Foundation Trust at 3 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 2 to 3 years
- Conditions the study is for
- Perinatal Asphyxia, Encephalopathy
- What is being tested?
- Xenon
- How many people
- 69 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Aug 2014to May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 3 years
- All sexes
- Child
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
Who may be able to join
- Surviving participants in the TOBY Xenon study
Who cannot join
- Lack of consent to participate
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Guys and St Thomas NHS Trust
London
Imperial College London NHS Healthcare Trust
London
University College London Hospital NHS Foundation Trust
London
About this study
Official title: Neurological Outcome After 24 Months of Age Following Treatment With Xenon Combined With Moderate Hypothermia After Perinatal Asphyxia
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.
- Conditions
- Perinatal Asphyxia, Encephalopathy
- Being tested
- Xenon
- Medical subject headings
- Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XenonDrug
Also called Lenoxe
Inhaled xenon gas given via purposely designed ventilator
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Xenon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 2-3 years of age
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
Measured: at 2-3 years of age
Secondary outcomes (1)
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).
Measured: At 2-3 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study startAug 2014
- Primary completionJun 2017
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal AsphyxiaStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David A Edwards, FMedSci, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968861
- Sponsor's protocol ID
- IRAS157755
- Status last verified
- May 2019
- First submitted
- 14 May 2019
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurological Outcome After 24 Months of Age Following Treatment With Xenon Combined With Moderate Hypothermia After Perinatal Asphyxia
- ClinicalTrials.gov ID
- NCT03968861
- Acronym / sponsor ID
- IRAS157755
- Conditions
- Perinatal Asphyxia, Encephalopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Drug: XenonSurviving children allocated to inhaled xenon combined with moderate hypothermia in the TOBY-Xe trial |
Who may qualify
- Ages
- 2 to 3 years
- Sex
- All
- Age groups
- Child
- 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
Key inclusion criteria (1 listed)
- Surviving participants in the TOBY Xenon study
Key exclusion criteria (1 listed)
- Lack of consent to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XenonAlso: LenoxeInhaled xenon gas given via purposely designed ventilator | Drug | 30% Xenon for 24 hours combined with moderate hypothermia |
Primary outcome
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
1 secondary outcome
Grade of disability
Time frame: At 2-3 years of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
Related trials for Perinatal Asphyxia
Not yet recruitingPhase 2/3
Intranasal Stem Cells to Treat Perinatal Brain Injury to Combat Cerebral Palsy
Perinatal Arterial Ischemic Stroke, Perinatal Asphyxia
Not yet recruitingObservational study
EEG-Based Decision-Support Algorithm for Hypoxic-Ischemic Encephalopathy in Term Newborns
Hypoxic-Ischemic Encephalopathy, Perinatal Asphyxia
RecruitingObservational study
Optimization of Routine Obstetric and Neonatal Care in the Management of Severe Perinatal Asphyxia in Term or Near-term Newborns: Analysis of Sub-optimal Care
Perinatal Asphyxia
Active, not recruitingPhase 4
Early Hydrocortisone Versus Regular Treatment in Shock in Extremely Preterm Neonates - an Open Randomized Controlled Trial
Shock, Preterm Birth Complication
RecruitingEarly Phase 1
Feasibility and Safety of Intranasally Administered Breast Milk in HIE
Hypoxic Ischaemic Encephalopathy (HIE), Hypoxic Ischemic Encephalopathy of Newborn
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Edwards, FMedSci principal investigator
King's College London
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perinatal Asphyxia and Encephalopathy, run by Guy's and St Thomas' NHS Foundation Trust at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores on Bayley scales of infant and toddler development (time frame: at 2-3 years of age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019; AzTrials last refreshed its copy on 8 Nov 2026.