Understanding near fatal asthma in children and young people
Near Fatal Asthma in Children and Young People
University of Edinburgh · NCT05632588
This study looks at how often children and young people aged 5-15 in the UK and Republic of Ireland experience near fatal asthma attacks and what factors might increase their risk.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 5 Years to 15 Years |
| Sex | All |
| Sponsor | University of Edinburgh (other) |
| Locations | 1 site (Edinburgh) |
| Trial ID | NCT05632588 on ClinicalTrials.gov |
What this trial studies
This observational study aims to report the frequency and risk factors associated with near fatal asthma (NFA) attacks in children and young people aged 5-15 years in the UK and Republic of Ireland. It will analyze clinical care practices and estimate future asthma risks, providing insights into how to modify risk factors. The study will also explore socio-demographic factors linked to NFA, including environmental influences like pollution and weather. By detailing medical management variations, the findings could inform future clinical trials and guideline development for standardized care.
Who should consider this trial
Good fit: Ideal candidates are children and young people aged 5-15 years who have survived an acute episode of near fatal asthma.
Not a fit: Patients who do not meet the criteria for near fatal asthma or are outside the age range will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved identification and management of risk factors for near fatal asthma in children and young people.
How similar studies have performed: While this study focuses on a specific aspect of asthma management, similar observational studies have shown success in identifying risk factors and improving clinical outcomes.
Eligibility criteria
Show full inclusion / exclusion 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 this trial is running
Edinburgh
- University of Edinburgh — Edinburgh, United Kingdom (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Near Fatal Asthma