Treating breathing difficulties in young children diagnosed with bronchiolitis

Not Applicable

Completed

• Conditions: Specialty: Children, Primary sub-specialty: Respiratory and Cystic Fibrosis; UKCRC code/ Disease: Infection/ Other viral diseases, Respiratory/ Other acute lower respiratory infections; Respiratory; Infection/ Other viral diseases, Respiratory

• Registration Number: ISRCTN75766048
• Lead Sponsor: Alder Hey Children's NHS Foundation Trust

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30428935 protocol 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35264343/ Core outcome set development results (added 11/03/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-18
• Study Completion: 2018-09-30
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 115

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

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
There are no secondary outcome measures