Burden of RSV Infection in young Children in European countries (BRICE)

Status: Closed to Recruitment

Population: Paediatric

Disease group: RSV

Funder: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Principal Investigator: Dr. Simon Drysdale

Study Aims

Respiratory Syncytial Virus is one of the commonest causes for hospital admission in young children and sadly in some countries, causes many deaths. It can be responsible for the common cold but in children under two, can cause an infection in the lungs, often with wheezing. 

In this study, we will collect data to better understand how frequently RSV occurs in young children, under 2 years of age, during RSV season months and annually. In addition, we will compare children hospitalized due to RSV infection and those without respiratory tract infection to understand whether RSV infection increases the risk of wheezy episodes after discharge. Studying the wheeze associated with RSV infection will help to understand the impact and complications of an RSV infection. The study also explores the costs and quality of life impact of RSV hospitalisation.  

This study contributes to the bigger picture of RSV prevention; data from this study will help to inform an immunisation strategy for RSV as these are currently in development.  

What does participating in the study involve?

This study is a questionnaire study and so is not testing a drug or changing treatment. It is looking at children in hospital because of RSV infection, plus a control group who don’t have a respiratory infection.   

Firstly, we take consent from families to take part, which is always optional. We collect health information that was recorded during a child’s RSV hospital admission. This includes date of birth, gender, details of medical history, parents’ allergy and asthma history, and details of the current hospital stay.  

We complete questionnaires with the family while their child is hospitalized. The questionnaires ask about the child’s quality of life before and during RSV hospitalisation, as well as indirect and additional costs associated with the RSV hospitalisation, including a parent’s ability to work and carry out usual activities. This is valuable information to be able to support the funding and development of a vaccine to prevent RSV. 

We will also complete questionnaires around the time of discharge, collecting data on what happened during the hospitalisation. Families then complete a follow-up questionnaire by phone app, every two months, for a period of 1 year. This contains questions about wheezing episodes, health care-related costs and any more medical attendances for the child.   

The collected information is always anonymised – we don’t use the child’s name, but a number to link the information. There are no follow-up visits to the hospital required for this study. We’re proud to be taking part in this important study, which will include thousands of families across Europe, in order to help get an RSV vaccine ready for use in the UK and beyond. If you’d like to know more about this study please feel free to read the patient information sheet or get in touch on the email below. 

For more information about the study, please contact the study team: researchforchildren@sgul.ac.uk