Treating breathing difficulties in young children diagnosed with bronchiolitis

Non-invasive ventilation for the management of children with bronchiolitis: a feasibility study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN75766048

Enrollment

115

Registered

2017-12-18

Start date

2016-02-12

Completion date

Unknown

Last updated

2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Specialty: Children, Primary sub-specialty: Respiratory and Cystic Fibrosis

Interventions

This study is a feasibility study to inform the design of a future trial of non-invasive ventilation (high flow nasal cannula (HFNC) and/or continuous positive air way pressure (CPAP)) in the manageme

telephone/Skype software interviews (parents/carers only (n=15)) or a Delphi consensus survey (health care professionals (n=300) and parents/carers (n=34). The workshops include three

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Parents/carers of a hospitalised child (including emergency department (ED) attenders), aged 0-24 months, with a clinical diagnosis of bronchiolitis defined as per NICE Bronchiolitis Guidelines (2015): Diagnose bronchiolitis if the child has a coryzal prodrome lasting 1 to 3 days, followed by: persistent cough and either tachypnoea or chest recession (or both) and either wheeze or crackles on chest auscultation (or both) 2. HCPs who have at least six months experience in managing children diagnosed with bronchiolitis in the following clinical locations: ED, acute assessment unit, medical wards and critical care unit

Exclusion criteria

Exclusion criteria: Parents/legal representatives who are unable to consent or unable to participate in the workshops or interviews in English. Due to the amount of planned topics to cover it would be impractical to conduct the workshop or interviews using an interpreter.

Design outcomes

Primary

Measure	Time frame
At the end of the NOVEMBR feasibility study, the trialists aim to be in a position to decide whether to proceed with a future definitive trial comparing different methods of non-invasive ventilation for managing children with bronchiolitis. If this is the case, a provisional study design and protocol will be written which is acceptable to important stakeholders. A bronchiolitis core outcome set will have been developed to improve standardisation, measurement and reporting of outcomes.This is done through stakeholder workshops, interviews and Delphi surveys.	—

Measure

Time frame

At the end of the NOVEMBR feasibility study, the trialists aim to be in a position to decide whether to proceed with a future definitive trial comparing different methods of non-invasive ventilation for managing children with bronchiolitis. If this is the case, a provisional study design and protocol will be written which is acceptable to important stakeholders. A bronchiolitis core outcome set will have been developed to improve standardisation, measurement and reporting of outcomes.This is done through stakeholder workshops, interviews and Delphi surveys.

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 23, 2026