Clinical trial NCT05550545: Infant RSV Infections and Health-related Quality of Life of Families
Official title: ResQ Family: Impact of Respiratory Syncytial Virus (RSV) Hospitalisation on Quality of Life of Families - A Multi-Country Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: RSV Infection
Quality of Life
Infant ALL
Caregiver Burden
Family
Keywords: RSV
Respiratory syncytial virus
quality of life
health literacy
infants
children
caregiver burden
Lead sponsor: Global Foundation for the Care of Newborn Infants
Sponsor class: OTHER
Collaborators: name: Respiratory Syncytial Virus Foundation (ReSViNET)
name: European Society for Paediatric Research (ESPR)
name: Union of European Neonatal and Perinatal Societies (UENPS)
First posted: 2022-09-22
Enrollment: 120
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents or caregivers of children younger than 24 months of age with a hospitalisation for at least 12 hours due to RSV infection in Germany, Sweden, Italy or France.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Parents or caregivers of children younger than 24 months of age with a hospitalisation for at least 12 hours due to RSV infection
* Living in Germany, Sweden, Italy or France
* The diagnosis can either be confirmed by a test such as ELISA/IFT/PCR from nasal secretion, sputum or throat swab or by a doctor based on specific symptoms typically during the RSV season
* They can be reached during or after hospitalisation, ideally right after the discharge from hospital but at least within four weeks after hospital admission

Primary outcomes:
measure: Health-related quality of life of parents/caregivers and family functioning
timeFrame: Baseline (Day 0)
measure: Health-related quality of life of parents/caregivers and family functioning
timeFrame: 6 weeks follow-up (Week 6)
Secondary outcomes:
measure: Socio-demographics
timeFrame: Baseline (Day 0)
measure: Child's co-morbidities
timeFrame: Baseline (Day 0)
measure: Child's symptoms during RSV infection and hospitalisation
timeFrame: Baseline (Day 0)
measure: Child's symptoms after RSV infection and hospitalisation
timeFrame: 6 weeks follow-up (Week 6)
measure: Other
timeFrame: Baseline (Day 0)
measure: Other
timeFrame: 6 weeks follow-up (Week 6)
Other outcomes:
Locations:
city: Munich
country: Germany
facility: EFCNI
state: Bavaria
Study officials:
affiliation: Global Foundation for the Care of Newborn Infants
name: Johanna Kostenzer, PhD
role: PRINCIPAL_INVESTIGATOR
References: