RSV InfectionResQFamilyNCT05550545
Infant RSV Infections and Health-related Quality of Life of Families
An observational study of RSV Infection and Quality of Life, run by Global Foundation for the Care of Newborn Infants at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- RSV Infection, Quality of Life, Infant ALL
- What is being tested?
- cohort study
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 29 Sep 2022to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
EFCNI
Munich, Bavaria, 81379
Christina Tischer, PhD
About this study
Official title: ResQ Family: Impact of Respiratory Syncytial Virus (RSV) Hospitalisation on Quality of Life of Families - A Multi-Country Study
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.
Read the 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.
- Conditions
- RSV Infection, Quality of Life, Infant ALL, Caregiver Burden, Family
- Being tested
- cohort study
- Keywords
- RSV, Respiratory syncytial virus, quality of life, health literacy, infants, children, caregiver burden
- Medical subject headings
- Respiratory Syncytial Virus Infections, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cohort studyOther
Please note that this is an observational study; not applicable
| Study group | Role | What they receive |
|---|---|---|
| Parents/caregivers of RSV-infected infants | Not described Receives: Other: cohort study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life of parents/caregivers and family functioning
The 36-item version of the Pediatric Quality of Life Inventory Family Impact Module (PedsQLTM FIM) was used to assess the quality of life of parents/caregiver when the child was infected and hospitalized for RSV. It composes of six scales measuring parent self-reported functioning: 1) Physical functioning (6 items), 2) Emotional functioning (5 items), 3) Social functioning (4 items), 4) Cognitive functioning (5 items), 5) Communication (3 items), 6) Worry (5 items), and in addition two scales measuring parent-reported family functioning: 7) Daily activities (3 items) and 8) Family relationships (5 items). Each of the items have five Likert response options: 0 = never a problem, 1 = almost never, 2 = sometimes, 3 = often, 4= almost always. Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher scores indicate better functioning (less negative impact).
Measured: Baseline (Day 0)
Health-related quality of life of parents/caregivers and family functioning
The 36-item version of the Pediatric Quality of Life Inventory Family Impact Module (PedsQLTM FIM) was used to assess the quality of life of parents/caregiver when the child was infected and hospitalized for RSV. It composes of six scales measuring parent self-reported functioning: 1) Physical functioning (6 items), 2) Emotional functioning (5 items), 3) Social functioning (4 items), 4) Cognitive functioning (5 items), 5) Communication (3 items), 6) Worry (5 items), and in addition two scales measuring parent-reported family functioning: 7) Daily activities (3 items) and 8) Family relationships (5 items). Each of the items have five Likert response options: 0 = never a problem, 1 = almost never, 2 = sometimes, 3 = often, 4= almost always. Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher scores indicate better functioning (less negative impact).
Measured: 6 weeks follow-up (Week 6)
Secondary outcomes (6)
Socio-demographics
Parental self-report - self-designed questions: socio-demographics (parents/caregiver), risk factors (smoking, allergic diseases), place of living, birth weight (child, categories and in grams), RSV prophylaxis, breastfeeding, day-care attendance
Measured: Baseline (Day 0)
Child's co-morbidities
Parental self-report - self-designed questions: pre-existing health-conditions before or apart from the current recent hospitalisation due to RSV
Measured: Baseline (Day 0)
Child's symptoms during RSV infection and hospitalisation
Parental self-report - self-designed questions:
RSV diagnose (child), duration of hospitalisation (in days), supportive care measure in hospital, feelings (parents) in relation to the hospitalisation of the child (categories), presence with the child receiving special/intensive care, duration of symptoms (up to 7 days and more), child's behaviour (categories), worry of parents/caregiver about symptoms (categories)
Measured: Baseline (Day 0)
Child's symptoms after RSV infection and hospitalisation
Parental self-report - self-designed questions:
Duration of symptoms (in days), child's behaviour, worry of parents/caregiver about symptoms (categories)
Measured: 6 weeks follow-up (Week 6)
Other
Parental self-report - self-designed questions:
Health literacy, support structures, loss of work productivity (in hours), subjective assessment of parental health status (categories: 1=very bad to 10 = excellent), overall impact of the entire RSV episode (open question)
Measured: Baseline (Day 0)
Other
Parental self-report - self-designed questions:
Loss of work productivity (in hours), subjective assessment of parental health status (categories: 1=very bad to 10 = excellent), overall impact of the entire RSV episode (open question)
Measured: 6 weeks follow-up (Week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start29 Sep 2022
- Primary completionMay 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RSV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Global Foundation for the Care of Newborn Infants
- Sponsor type
- University, hospital or other
- Collaborators
- Respiratory Syncytial Virus Foundation (ReSViNET), European Society for Paediatric Research (ESPR), Union of European Neonatal and Perinatal Societies (UENPS)
- Responsible party
- Principal investigator, Johanna Kostenzer, Global Foundation for the Care of Newborn Infants
- Investigators
- Johanna Kostenzer, PhD, Principal investigator, Global Foundation for the Care of Newborn Infants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550545
- Sponsor's protocol ID
- 2022-3307
- Acronym
- ResQFamily
- Status last verified
- Oct 2022
- First submitted
- 12 Sep 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Trautmannsberger I, Bosl S, Adamek I, Apfelbacher C, Beutels P, Essers B, Ravens-Sieberer U, Weil-Olivier C, Nenna R, Wetzke M, Mader S, Tischer C, Zimmermann LJI; ResQ Family study group. Higher severity of infant RSV infections is associated with lower parental quality of life - a European observational study. J Patient Rep Outcomes. 2026 Jul 24;10(1):127. doi: 10.1186/s41687-026-01157-3.
PubMed 42507294Trautmannsberger I, Plagg B, Adamek I, Mader S, de Luca D, Esposito S, Silfverdal SA, Zimmermann LJI, Tischer C; ResQ Family study group. The Multifaceted Burden of Respiratory Syncytial Virus (RSV) Infections in Young Children on the Family: A European Study. Infect Dis Ther. 2024 Jul;13(7):1531-1573. doi: 10.1007/s40121-024-00989-0. Epub 2024 May 20.
PubMed 38767780
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ResQ Family: Impact of Respiratory Syncytial Virus (RSV) Hospitalisation on Quality of Life of Families - A Multi-Country Study
- ClinicalTrials.gov ID
- NCT05550545
- Acronym / sponsor ID
- ResQFamily / 2022-3307
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Global Foundation for the Care of Newborn InfantsUniversity, hospital or other
- Collaborators
- Respiratory Syncytial Virus Foundation (ReSViNET), European Society for Paediatric Research (ESPR), Union of European Neonatal and Perinatal Societies (UENPS)
- Study start
- 29 Sep 2022 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parents/caregivers of RSV-infected infants | – | Other: cohort study |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cohort studyPlease note that this is an observational study; not applicable | Other | Parents/caregivers of RSV-infected infants |
Primary outcome
Health-related quality of life of parents/caregivers and family functioning
Time frame: Baseline (Day 0)
The 36-item version of the Pediatric Quality of Life Inventory Family Impact Module (PedsQLTM FIM) was used to assess the quality of life of parents/caregiver when the child was infected and hospitalized for RSV. It composes of six scales measuring parent self-reported functioning: 1) Physical functioning (6 items), 2) Emotional functioning (5 items), 3) Social functioning (4 items), 4) Cognitive functioning (5 items), 5) Communication (3 items), 6) Worry (5 items), and in addition two scales measuring parent-reported family functioning: 7) Daily activities (3 items) and 8) Family relationships (5 items). Each of the items have five Likert response options: 0 = never a problem, 1 = almost never, 2 = sometimes, 3 = often, 4= almost always. Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher scores indicate better functioning (less negative impact).
Health-related quality of life of parents/caregivers and family functioning
Time frame: 6 weeks follow-up (Week 6)
The 36-item version of the Pediatric Quality of Life Inventory Family Impact Module (PedsQLTM FIM) was used to assess the quality of life of parents/caregiver when the child was infected and hospitalized for RSV. It composes of six scales measuring parent self-reported functioning: 1) Physical functioning (6 items), 2) Emotional functioning (5 items), 3) Social functioning (4 items), 4) Cognitive functioning (5 items), 5) Communication (3 items), 6) Worry (5 items), and in addition two scales measuring parent-reported family functioning: 7) Daily activities (3 items) and 8) Family relationships (5 items). Each of the items have five Likert response options: 0 = never a problem, 1 = almost never, 2 = sometimes, 3 = often, 4= almost always. Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher scores indicate better functioning (less negative impact).
6 secondary outcomes
Socio-demographics
Time frame: Baseline (Day 0)
Child's co-morbidities
Time frame: Baseline (Day 0)
Child's symptoms during RSV infection and hospitalisation
Time frame: Baseline (Day 0)
Child's symptoms after RSV infection and hospitalisation
Time frame: 6 weeks follow-up (Week 6)
Other
Time frame: Baseline (Day 0)
Other
Time frame: 6 weeks follow-up (Week 6)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Derived from this study: PubMed 42507294Trautmannsberger I, Bosl S, Adamek I, Apfelbacher C, Beutels P, Essers B, Ravens-Sieberer U, Weil-Olivier C, Nenna R, Wetzke M, Mader S, Tischer C, Zimmermann LJI; ResQ Family study group. Higher severity of infant RSV infections is associated with lower parental quality of life - a European observational study. J Patient Rep Outcomes. 2026 Jul 24;10(1):127. doi: 10.1186/s41687-026-01157-3.
- Derived from this study: PubMed 38767780Trautmannsberger I, Plagg B, Adamek I, Mader S, de Luca D, Esposito S, Silfverdal SA, Zimmermann LJI, Tischer C; ResQ Family study group. The Multifaceted Burden of Respiratory Syncytial Virus (RSV) Infections in Young Children on the Family: A European Study. Infect Dis Ther. 2024 Jul;13(7):1531-1573. doi: 10.1007/s40121-024-00989-0. Epub 2024 May 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johanna Kostenzer, PhD principal investigator
Global Foundation for the Care of Newborn Infants
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of RSV Infection and Quality of Life, run by Global Foundation for the Care of Newborn Infants at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christina Tischer, PhD (+49 (0)89 / 89083260, research@efcni.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life of parents/caregivers and family functioning (time frame: Baseline (Day 0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05550545, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022.