Near Fatal Asthma in Children and Young People

NCT ID: NCT05632588

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-31
• Study Completion Date: 2026-04-30

Brief 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.

Conditions

Near Fatal Asthma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Interventions

Observational study

Observational surveillance study

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Edinburgh

Edinburgh, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Facility Contacts

Steve Cunningham

Role: primary

steve.cunningham@ed.ac.uk

01313120453

Role: backup

steve.cunningham@ed.ac.uk

Other Identifiers

AC22026

Identifier Type: -

Identifier Source: org_study_id