Overview

Non-invasive ventilation in the management of children with bronchiolitis: A feasibility study

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

The specific aims of the NOVEMBR feasibility study are:

  1. To develop a core outcome set (COS) for use in future clinical trials in bronchiolitis (see diagram 1).
  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.

Figure 1: Development of a bronchiolitis core outcome set (COS)

Diagram1

Collaborators

Hospital departments taking part

The study is open across the country. To see if your hospital is taking part in this study please go to recruiting centres.

Study funder

This study has been funded by the National Institute for Health Research.

Study organiser

Alder Hey Children’s NHS Foundation Trust.

Study review and approval

The study has been reviewed by a research ethics committee, who have agreed the study is being conducted in a correct and appropriate manner. The study has also been approved by the Health Research Authority (HRA).

NOVEMBR Study Phase II – Delphi Survey

Important things that you need to know

  • You will be asked to complete two online surveysabout bronchiolitis.
  • Each survey will take approximately 15-20 minutes to complete
  • The survey will ask you rate on a scale the importance of a number of different outcomes.

Why have I been asked to take part?

We are inviting you to take part in this survey because either you are a parent with a child who has recently been diagnosed with bronchiolitis or you are a health care professional who has looked after children who have recently been diagnosed with bronchiolitis.

What are the possible disadvantages of taking part?

Completing the survey will take between 15 -20 minutes, although it doesn’t have to be done in a single sitting – you can complete it in part and come back to it later. We will send you e-mail reminders to complete the survey.

What are the possible benefits of taking part?

By taking part in this study, you will help us to make sure that the outcomes we include in the core set are relevant to healthcare professionals, children with bronchiolitis and their families. Participants who complete both rounds of the survey will be entered into a prize draw to win an iPad. Additionally, all participants will be provided with a certificate on completion of the survey.

Why are we doing this research?

Bronchiolitis is a common, viral, chest infection that affects babies and young children up to 2 years of age. Bronchiolitis usually occurs during the winter months (October – March). A small number of children (around 3 out of every 100) need to come into hospital for help with their breathing or feeding.

Children who come into hospital for help with their breathing often receive oxygen therapy. There are different ways to give oxygen therapy, including through a face mask, head box or nasal cannula. All of these interventions are used in current clinical practice.

Up until now, studies have used different ways of measuring the effects of treatment. This makes comparing the results of trials very difficult. The aim of this study is to agree a ‘core outcome set’. This is a list of outcomes that all trials in bronchiolitis should measure and report. Having a core outcome set will help to make sure that the results from all trials can be combined to get a better understanding of which treatments are best.

It is important that the outcomes included in a core set are relevant to everyone looking after children with bronchiolitis. We are therefore asking health care professionals and parents/legal representatives to take part in a special type of survey, called a Delphi survey. The results of this survey will show us which outcomes both health care professionals and parents/legal representatives agree are most important and should be included in the core outcome set.

What will happen if I agree to take part?

You will be asked to fill in an online survey where you rate the importance of a series of outcomes on a scale of 1 to 9 (low importance to extremely high importance). Once all participants have completed the survey, you will be asked to complete the same survey again. You will be shown the scores given by other people completing the survey and you will be given the option to either leave your scores the same or change them.

You will also be invited to participate in a consensus meeting on Thursday 14th June 2018.

Recruiting Centre and Participant Identification Centres

The following 1 sites are participating

 1 Alder Hey Children’s Hospital

The following 5 Participant Identification Centres are taking part

 1 Brighton & Sussex University Hospitals NHS Trust
 2 Countess of Chester Hospital NHS Foundation Trust
 3 County Durham and Darlington NHS Foundation Trust
 4 Wirral University Teaching Hospital NHS Foundation Trust
 5 Derby Teaching Hospitals NHS Foundation Trust

Trial Team

 

Contacts

Please feel free to contact the NOVEMBR study team by any of the means below:

Telephone


0151 794 9838

Address

Medicines for Children Clinical Trials Unit
Clinical Trials Research Centre
University of Liverpool
Institute of Child Health
Alder Hey Children's NHS Foundation Trust
Liverpool
L12 2AP