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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
Where Is This Study? (1 UK site)
University of Edinburgh
Edinburgh, United Kingdom
