Condition category
Respiratory
Date applied
18/09/2017
Date assigned
18/12/2017
Last edited
06/09/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Bronchiolitis is a very common respiratory condition that generally affects young babies and children up to two years of age. Symptoms include breathing difficulties, cough and poor feeding. Most children can be looked after at home but a small number of young children need to come into hospital for oxygen to treat their breathing difficulties. For a small number of children admitted to hospital their breathing difficulties will worsen and they will need to be admitted to intensive care. To try and prevent a child from worsening, health care professionals will provide treatments that will open up the small airways in their lungs. This is done by giving oxygen through the nose at either high pressures or at high flow rates. Importantly, it is not known which one of these two oxygen treatments is best or if they work. Due to the lack of research evidence, how and when these treatments are used in the UK varies a lot. The long term aim of this research is to find out the best way of treating breathing difficulties in children with bronchiolitis. Before this can be done it is necessary to know if this research is possible. This study includes a national survey of healthcare professionals, and will collect information on the number of children admitted to hospital. A series of focus group workshops and an online survey for healthcare professionals and parents are run to discuss opinions on treatment and to find out which outcomes of treatment are most important. The aim of this study is to be able to decide if a large trial comparing different ways of treating children with bronchiolitis in hospital with breathing difficulties is possible and warranted.

Who can participate?
Parents/carers of hospitalised children aged 0-24 months who are diagnosed with bronchiolitis and health care professionals with at least six months of experiencing managing children diagnosed with bronchiolitis.

What does the study involve?
Participants are invited to participate in focus groups, a Delphi survey or a telephone interview (parents/carers only). The workshop involves three focus groups to cover the identifying and prioritising outcomes, trial design and consent. The parent telephone interviews concentration on identifying and prioritising outcomes. The Delphi survey ask participants to rate each outcome (determined by literature review, workshops and telephone interviews) for importance. A national survey is sent to paediatricians at NHS hospital asking about bronchiolitis management. Participants in the workshops, interview and survey are invited to attend an end of study event where the study data is presented and they agree on the future trial design and core outcome set.

What are the possible benefits and risks of participating?
There are no direct benefits or risks with participation.

Where is the study run from?
This study is being run by Alder Hey NHS Foundation Trust (UK) and takes place in hospitals in the UK.

When is the study starting and how long is it expected to run for?
February 2016 to September 2018

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Mrs Clare van Miert

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Clare van Miert

ORCID ID

http://orcid.org/0000-0003-0287-9832

Contact details

Clinical Research Division
2nd Floor Institute in the Park
Alder Hey Children’s NHS Foundation Trust
Eaton Road
Liverpool
L12 2AP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

20745

Study information

Scientific title

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

Acronym

NOVEMBR

Study hypothesis

The long term aim of the study is to find out how to best provide respiratory support to children with bronchiolitis when they are admitted to hospital.

Primary aims of the study are to:
1. To develop a core outcome set (COS) for use in future clinical trials in bronchiolitis
2. To explore issues critical to the design of a randomised controlled trial of non-invasive ventilation in infants with bronchiolitis
3. To comprehensively assess current UK practice as regards bronchiolitis management, potential trial capability and acceptability

Ethics approval

Health Research Authority, Yorkshire & The Humber – South Yorkshire Research Ethics Committee, 15/01/2016, ref: 16/YH/0012

Study design

Observational; Design type: Qualitative

Primary study design

Observational

Secondary study design

Qualitative study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

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

Intervention

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 management of children with bronchiolitis.

A systematic review is undertaken to identify outcomes used in bronchiolitis trials and how they are measured.

Eligible stakeholders are invited to participate with either: focus group workshop (health care professionals (n=80) and parents/carers (n=20); 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 focus groups which covers identification and prioritisation of outcomes, trial design and consent (prospective and research without prior consent).

Parent telephone/Skype software interviews concentrate on identification and prioritisation of outcomes.

A list of collated outcomes identified from the systematic review, workshops and interviews are included into a Delphi survey. Stakeholders are asked to rate each outcome for importance on a Likert scale.

A national survey of practice are sent to lead paediatricians at NHS hospitals. The survey covers aspects of bronchiolitis management, criteria for initiating/weaning non-invasive ventilation and capability and capacity for running a clinical trial. In addition to the survey study sites are asked to complete a screening log to collect admission data over a four week period during the bronchiolitis season.

Stakeholders involved with either the workshops, interviews or Delphi survey are invited to attend an end of study event. The study data is presented to the attendees. The attendees are invited to participate in a final exercise to agree consensus over the future trial design and core outcome set.

Intervention type

Other

Phase

Drug names

Primary outcome measure

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

There are no secondary outcome measures

Overall trial start date

12/02/2016

Overall trial end date

30/09/2018

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 115; UK Sample Size: 115

Participant 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.

Recruitment start date

12/02/2016

Recruitment end date

31/07/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Alder Hey NHS Foundation Trust (lead centre)
Eaton Road
Liverpool
L12 2AE
United Kingdom

Trial participating centre

Countess of Chester Hospital
Liverpool Road
Chester
CH2 1UL
United Kingdom

Trial participating centre

Arrowe Park Hospital
Arrowe Park Road
Upton Wirral
CH49 5PE
United Kingdom

Trial participating centre

Royal Alexandra Children’s Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom

Trial participating centre

Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Trial participating centre

Darlington Memorial Hospital Hollyhurst Road
Darlington
Darlington
DL3 6HX
United Kingdom

Trial participating centre

Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

Alder Hey Children's NHS Foundation Trust

Sponsor details

Alder Hey Hospital
Eaton Road
West Derby
Merseyside
Liverpool
L12 2AP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The findings of the feasibility study will be presented at relevant national and international meetings and conferences (including the Royal College of Paediatrics and Child Health annual meeting), and will be submitted for publication in peer reviewed medical journals.

The developed bronchiolitis core outcome set will also be published on the Core Outcome Measures in Effectiveness Trials (COMET) initiative website: http://www.comet-initiative.org/

Protocol is currently being drafted for publication.

IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

30/09/2019

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/09/2018: The following changes were made to the trial record: 1. The overall trial end date was changed from 31/07/2018 to 30/09/2018. 2. The intention to publish date was changed from 31/07/2019 to 30/09/2019. 05/01/2018: Internal review.