Near Fatal Asthma in Children and Young People

Recruiting

• Conditions: Near Fatal Asthma

• Registration Number: NCT05632588
• Lead Sponsor: University of Edinburgh

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-25
• Study Start: 2022-10-31
• Study First Submitted QC: 2022-11-29
• Study First Posted: 2022-11-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-21
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of cases of Near Fatal Asthma reported to British Paediatric Surveillance Unit	18 months	Descriptive data

Secondary Outcome Measures

Name	Time	Method
Detailed analysis of the clinical, social and environmental characteristics of those who experience NFA.	18 months	Descriptive data
Reporting of the 12 and 24 months following an episode of NFA, estimating the future risk of a health-related asthma event and the healthcare that is provided to those experiencing NFA.	42 months	Descriptive data
Detailed analysis of the care provided to CYP who experience NFA at the time of the event, during emergency, in patient and critical care.	18 months	Descriptive data

Trial Locations

Locations (1)

University of Edinburgh; 🇬🇧 Edinburgh, United Kingdom