CompletedNot Applicable

Near Fatal Asthma in Children and Young People

United Kingdom60 participantsStarted 2022-10-31

Plain-language 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). 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.

Who can participate

Age range

5 Years – 15 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of cases of Near Fatal Asthma reported to British Paediatric Surveillance Unit

Timeframe: 18 months

Trial details

NCT IDNCT05632588

SponsorUniversity of Edinburgh

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-04-30

View on ClinicalTrials.gov More Near Fatal Asthma trials