Infant RSV Infections and Health-related Quality of Life of Families — ResQFamily  

Quality of Life Clinical Trial

Official title: ResQ Family: Impact of Respiratory Syncytial Virus (RSV) Hospitalisation on Quality of Life of Families - A Multi-Country Study

Status Recruiting

Clinical Trial Summary

Until today, there is only little information available on how severe RSV infection leading to hospitalisation of the infant impacts the quality of life of affected families. For the ResQ Family project, an online questionnaire will be used to survey parents or caregivers of children up to 24 months currently or recently hospitalised (length of hospital stay of at least 12 hours and hospital admission no longer than 4 weeks ago) due to RSV infection.

The aim of the ResQ Family project is to find out how infant RSV hospitalisation impacts the quality of life of affected children and their families. The goal is further to provide scientific evidence on the burden of RSV and raise awareness among all relevant stakeholders including healthcare professionals and patient representatives, decision-makers and the general public. The project will run until June 2024. Data collection will take place during the RSV season from fall 2022 to spring 2023 in four European countries: France, Germany, Italy, and Sweden.

Clinical Trial Description

Respiratory Syncytial Virus (RSV) is a very contagious virus and the most common cause of lower respiratory tract infections such as bronchiolitis and pneumonia in infants. By the age of two years, nearly all infants will be infected with RSV at least once. Globally, it is a leading cause of hospitalisations among young infants with approximately 33 million cases of acute lower respiratory infections causing more than three million hospitalisations each year in children younger than 5 years. While most RSV cases are mild, one can't predict which infants could get seriously ill and end up in hospital. This is because the course of the disease is unpredictable.

When the RSV infection of the child is severe and associated with hospitalisation, it may lead to intensive care unit admissions with use of supportive care such as mechanical ventilation. It may further result in long-term complications such as recurrent wheezing, reduced pulmonary function and asthma. Moreover, RSV-related hospitalisations can be associated with a significant burden on the entire family, causing considerable stress and increased loss of work productivity. Currently, there is a lack of adequate information on how severe RSV infection leading to hospitalisation of infants (< 2 years) impacts the quality of life of affected families.

To close this knowledge gap, the ResQ Family research project was initiated: ResQ Family:

Impact of Respiratory Syncytial Virus (RSV) hospitalisation on Quality of life of Families - a multi-country study. The project runs from December 2021 until June 2024 and covers four European countries: France, Germany, Italy and Sweden. Data will be collected between autumn 2022 and spring 2023, corresponding to a typical RSV season duration in temperate countries in the northern hemisphere.

The aim of the ResQ Family study is to find out how infant RSV hospitalisation impacts the quality of life of affected children and their families. The goal is further to provide scientific evidence on the burden of RSV and raise awareness among all relevant stakeholders including healthcare professionals and patient representatives, decision-makers and the general public.

An online questionnaire will be used to ask parents and caregivers of children experiencing (or having recently experienced) hospitalisation due to RSV infection to share their experiences and a follow-up will take place after six weeks. The study focuses on children up to 24 months with a hospital stay due to RSV infection of at least 12 hours in total. The hospital admission should not be longer than 4 weeks ago.

Experienced researchers and health care professionals renowned in the field of RSV as well as parent/patient representatives support the project as part of an external scientific advisory board and a project expert group.

EFCNI received a research grant from Sanofi in support of this independent study. ;

Related Conditions & MeSH terms

• Caregiver Burden
• Family
• Infant ALL
• Infections
• Quality of Life
• Respiratory Syncytial Virus Infections
• RSV Infection

• NCT number: NCT05550545
• Study type: Observational
• Source: European Foundation for the Care of Newborn Infants
• Contact: Christina Tischer, PhD
• Phone: +49 (0)89 / 89083260
• Email: research@efcni.org
• Status: Recruiting
• Start date: September 29, 2022
• Completion date: June 2024