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Study finishedN/A

Near Fatal Asthma in Children and Young People

Sponsor: University of Edinburgh

NCT ID: NCT05632588

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Observational study (other)
How long the study runs
Study runs about 42 months (dates as stated)
About the drug or intervention
Observational study — other: Observational surveillance study
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
5 Years to 15 Years
Who
All
Number of participants
60
Started
2022-10-31
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for near fatal asthma
  • • Clinical study - 60 participants
  • • 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)

Who can take part?

  • • Ages 5 Years to 15 Years
  • • Diagnosed with near fatal asthma

Where?

  • • Edinburgh - University of Edinburgh

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Near Fatal Asthma

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 5 Years - 15 Years
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ cardiopulmonary resuscitation as part of their presentation

What the study is looking for

  • ✓A child/young person is considered to have experienced an episode of near fatal asthma if they meeting any one of...
  • ✓Any child aged 5-15 years surviving\* an acute episode of asthma, who when presenting self-ventilating with severe...
  • ✓Pulse oxygen saturation below 92% despite maximal oxygen therapy (i.e. 10-15l/min oxygen flow via non-rebreather...
  • ✓pH \<= 7.2 and/or pCO2 \>=60mmHg or 8kPa
  • ✓Escalation to use of intravenous bronchodilator infusion

Who cannot take part

  • ✗CYP not meeting the case definition will be excluded. An expert panel (consisting of three clinicians) will...
See the full criteria
Inclusion Criteria: * A child/young person is considered to have experienced an episode of near fatal asthma if they meeting any one of the following: 1. 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: 1. Pulse oxygen saturation below 92% despite maximal oxygen therapy (i.e. 10-15l/min oxygen flow via non-rebreather mask) during acute presentation 2. pH \<= 7.2 and/or pCO2 \>=60mmHg or 8kPa 3. Escalation to use of intravenous bronchodilator infusion 2. 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. 3. Any child age 5-15 years surviving\* an acute episode of asthma for which he/she was invasively ventilated. * surviving to hospital discharge Exclusion Criteria: * CYP not meeting the case definition will be excluded. An expert panel (consisting of three clinicians) will adjudicate borderline cases.

Where Is This Study? (1 UK site)

University of Edinburgh

Edinburgh, United Kingdom

Hospital R&D contact (matched)

Accord Office

enquiries@accord.scot0131 242 3330
Data sourced from ClinicalTrials.gov · Last verified: 2026-06