Near Fatal AsthmaNCT05632588
Near Fatal Asthma in Children and Young People
An observational study of Near Fatal Asthma, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
This study will report the frequency, risks factors, clinical care and estimate the future asthma risk of children and young people (aged 5-15 years) experiencing a Delphi defined near fatal asthma (NFA) attacks in the United Kingdom (UK) and Republic of Ireland (ROI). Read more about this study
- Who is it for?
- Ages 5 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Near Fatal Asthma
- What is being tested?
- Observational study
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Oct 2022to 30 Apr 2026
- 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 5 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The number of children and young people identified who experience NFA within the 18-month surveillance period is not known, but is estimated to be c400 (from paediatric intensive care admission data). All UK and ROI hospitals where children may attend with acute asthma could be potential contributing sites. Each case will be followed up for 24 months following the near fatal asthma event.
Who may be able to join
- A child/young person is considered to have experienced an episode of near fatal asthma if they meeting any one of the following:
- Any child aged 5-15 years surviving* an acute episode of asthma, who when presenting self-ventilating with severe dyspnoea (e.g. inability to speak) and all the following features:
- Pulse oxygen saturation below 92% despite maximal oxygen therapy (i.e. 10-15l/min oxygen flow via non-rebreather mask) during acute presentation
- pH <= 7.2 and/or pCO2 >=60mmHg or 8kPa
- Escalation to use of intravenous bronchodilator infusion
- Any child aged 5-15 years surviving* an acute episode of asthma, who had a respiratory arrest and/or required cardiopulmonary resuscitation as part of their presentation.
- Any child age 5-15 years surviving* an acute episode of asthma for which he/she was invasively ventilated.
- surviving to hospital discharge
Who cannot join
- CYP not meeting the case definition will be excluded. An expert panel (consisting of three clinicians) will adjudicate borderline cases.
Trial locations and contacts
1 site in 1 country.
About this study
This study will report the frequency, risks factors, clinical care and estimate the future asthma risk of children and young people (aged 5-15 years) experiencing a Delphi defined near fatal asthma (NFA) attacks in the United Kingdom (UK) and Republic of Ireland (ROI). A greater understanding of the frequency and risk factors associated with NFA could help support children and young people (CYP), parents and clinicians to identify and modify risk, both independently and through a resulting clinical care pathway and also develop future research to improve effectiveness of interventions. The study will explore both commonly identified clinical factors, but also for the first time describe in detail the variance in medical management (acute and intensive care) that could lead to future clinical trials and guideline development to standardise care. The study will also describe, through data-linkage, socio-demographic factors associated with NFA, to include pollution, pollen, weather, viral prevalence that could lead to better care for higher risk CYP.
To encourage more consistent, less fragmented care following a near fatal asthma attack, the study will consider how care is provided subsequent to an NFA attack using British Paediatric Surveillance Unit (BPSU) surveillance at 12 and 24 month follow up.
- Conditions
- Near Fatal Asthma
- Being tested
- Observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
Observational surveillance study
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases of Near Fatal Asthma reported to British Paediatric Surveillance Unit
Descriptive data
Measured: 18 months
Secondary outcomes (3)
Detailed analysis of the clinical, social and environmental characteristics of those who experience NFA.
Descriptive data
Measured: 18 months
Detailed analysis of the care provided to CYP who experience NFA at the time of the event, during emergency, in patient and critical care.
Descriptive data
Measured: 18 months
Reporting of the 12 and 24 months following an episode of NFA, estimating the future risk of a health-related asthma event and the healthcare that is provided to those experiencing NFA.
Descriptive data
Measured: 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start31 Oct 2022
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Near Fatal AsthmaStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632588
- Sponsor's protocol ID
- AC22026
- Status last verified
- Jun 2026
- First submitted
- 25 Oct 2022
- Last updated
- 25 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near Fatal Asthma in Children and Young People
- ClinicalTrials.gov ID
- NCT05632588
- Acronym / sponsor ID
- AC22026
- Conditions
- Near Fatal Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 30 Nov 2022 (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.
This study will report the frequency, risks factors, clinical care and estimate the future asthma risk of children and young people (aged 5-15 years) experiencing a Delphi defined near fatal asthma (NFA) attacks in the United Kingdom (UK) and Republic of Ireland (ROI). A greater understanding of the frequency and risk factors associated with NFA could help support children and young people (CYP), parents and clinicians to identify and modify risk, both independently and through a resulting clinical care pathway and also develop future research to improve effectiveness of interventions. The study will explore both commonly identified clinical factors, but also for the first time describe in detail the variance in medical management (acute and intensive care) that could lead to future clinical trials and guideline development to standardise care. The study will also describe, through data-linkage, socio-demographic factors associated with NFA, to include pollution, pollen, weather, viral prevalence that could lead to better care for higher risk CYP.
To encourage more consistent, less fragmented care following a near fatal asthma attack, the study will consider how care is provided subsequent to an NFA attack using British Paediatric Surveillance Unit (BPSU) surveillance at 12 and 24 month follow up.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The number of children and young people identified who experience NFA within the 18-month surveillance period is not known, but is estimated to be c400 (from paediatric intensive care admission data). All UK and ROI hospitals where children may attend with acute asthma could be potential contributing sites. Each case will be followed up for 24 months following the near fatal asthma event.
Key inclusion criteria (8 listed)
- A child/young person is considered to have experienced an episode of near fatal asthma if they meeting any one of the following:
Key exclusion criteria (1 listed)
- CYP not meeting the case definition will be excluded. An expert panel (consisting of three clinicians) will adjudicate borderline cases.
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 |
|---|---|---|
| Observational studyObservational surveillance study | Other | – |
Primary outcome
Number of cases of Near Fatal Asthma reported to British Paediatric Surveillance Unit
Time frame: 18 months
Descriptive data
3 secondary outcomes
Detailed analysis of the clinical, social and environmental characteristics of those who experience NFA.
Time frame: 18 months
Detailed analysis of the care provided to CYP who experience NFA at the time of the event, during emergency, in patient and critical care.
Time frame: 18 months
Reporting of the 12 and 24 months following an episode of NFA, estimating the future risk of a health-related asthma event and the healthcare that is provided to those experiencing NFA.
Time frame: 42 months
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 25 Jun 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Near Fatal Asthma, run by University of Edinburgh at 1 site 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 8 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 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of cases of Near Fatal Asthma reported to British Paediatric Surveillance Unit (time frame: 18 months). 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 25 Jun 2026.