Syncytial Virus Respiratory InfectionPRSVHNCT04144816
Predictors of Respiratory Syncytial Virus (RSV) Hospitalizations in Infants
An observational study of Syncytial Virus Respiratory Infection and RSV Infection, run by Hospices Civils de Lyon.
Trial summary
The VRS (Respiratory Syncytial Virus) study group in Lyon is a working that aims to understand, predict and prevent the burden of disease caused by human respiratory syncytial virus (RSV) infection in infants. Read more about this study
- Who is it for?
- Ages 1 day to 4 daysHealthy volunteers can take part
- Conditions the study is for
- Syncytial Virus Respiratory Infection, RSV Infection, Respiratory Syncytial Virus Infections
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- Oct 2019to Oct 2020
- 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 1 day to 4 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Birth cohort of 5 000 infants of the general population recruited from the HCL (Public hospital of Lyon) maternity wards during the first days after birth
Who may be able to join
- Children born alive at participating centers.
- Parents living in the Rhone Alpes Auvergne region
Who cannot join
- Parents non-willing to participate
- Parents living outside the region
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Exploring the Role of Socio Demographic, Clinical Risk Factors, Cord Specific Antibody at Birth, and Virus Characteristic, in Respiratory Syncytial Virus (RSV) in Hospitalized vs Ambulant Infants
The VRS (Respiratory Syncytial Virus) study group in Lyon is a working that aims to understand, predict and prevent the burden of disease caused by human respiratory syncytial virus (RSV) infection in infants. Incidence of RSV-associated hospitalization in the first year of life was estimated at 14.5 (95% CI 13.4-15.6) per 1000 births in a cohort study in Lyon, France. Related direct medical annual costs were estimated for this cohort at 364,269€, mostly attributed to children born during the RSV season (231,959€) and children born premature (108,673€). This study will combine existing hospital specimens and databases to determine the respective role of socio demographic factors, clinical risk factors, level of cord specific antibody at birth, and virus characteristic in the Respiratory Syncytial Virus (RSV) Hospitalization outcome in Infants.
Regarding the introduction of a new RSV vaccine and RSV-specific neutralizing antibodies, these data are of prime importance to guide future vaccine policies.
Read the detailed description
Objective:
To determine the main predictors of Respiratory Syncytial Virus (RSV) Hospitalizations in Infants
Study design:
Prospective epidemiological, observational, one-center cohort study with sample collection.
Study population:
Birth cohort of infants born in Lyon before and during the RSV circulation period (October to march) with a follow-up until one year old (from birth until the age of 1 year maximum):
- Estimate Birth cohort (n=5,000).
- Estimate number of RSVH case (n=110).
- Estimate number of Blood cordon associated with a RSVH (Respiratory Syncytial Virus Human) case (n=60)
- Conditions
- Syncytial Virus Respiratory Infection, RSV Infection, Respiratory Syncytial Virus Infections, RSV Bronchiolitis
- Being tested
- Not applicable (no intervention)
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable (no intervention)Other
Not applicable (no intervention)
| Study group | Role | What they receive |
|---|---|---|
| Passive Birth Cohort | This will be a multicenter, prospective, observational cohort study conducted across the Lyon Public hospital maternity (HFME : Hospital for women, mother and children, Croix-Rousse, Lyon-Sud) recruited from the general population.
Infants born between October 2019 and march 2020. At birth the remains (after diagnosis use) of cord blood samples will be store. Groups of RSVh cases and control will be class at one year of age using the hospital data (RSV must be confirmed by RT-PCR). Parents will be informed of the protocol. If enrolled available hospital data will be use and RSV serology testing perform on the store blood cordon. Receives: Other: Not applicable (no intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases included in the cohort with RT-PCR (Retrotranscription) confirmed RSV hospitalization occurring from birth until the age of 1 year
Cases were defined as a new admission to one of the conventional pediatric hospital departments with a RSV positive sample during the hospital stay the first 3 years of life.
Measured: 1 year after inclusion
Number of cases included in the cohort with RT-PCR confirmed RSV hospitalization occurring from birth until the age of 3 years.
Cases were defined as a new admission to one of the conventional pediatric hospital departments with a RSV positive sample during the hospital stay the first 3 years of life.
Measured: 3 years after inclusion
Secondary outcomes (2)
Quantitative level of anti-RSV IgG measure
The quantitative level of anti-RSV IgG at birth in blood cord cordon will be compare between the cases group and the control group (No admission to one of the conventional pediatric hospital departments with a RSV positive sample during the hospital stay the first 3 years of life)
Measured: 3 years after inclusion
Quantitative level of anti-RSV IgG (Immunoglobulin G) measure
The quantitative level of anti-RSV IgG at birth in blood cord cordon will be compare between the cases group and the control group (No admission to one of the conventional pediatric hospital departments with a RSV positive sample during the hospital stay the first 3 years of life)
Measured: 3 years after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study startOct 2019 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Syncytial Virus Respiratory InfectionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144816
- Sponsor's protocol ID
- PRSVH_2019
- Acronym
- PRSVH
- Status last verified
- Oct 2019
- First submitted
- 18 Oct 2019
- Last updated
- 30 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Role of Socio Demographic, Clinical Risk Factors, Cord Specific Antibody at Birth, and Virus Characteristic, in Respiratory Syncytial Virus (RSV) in Hospitalized vs Ambulant Infants
- ClinicalTrials.gov ID
- NCT04144816
- Acronym / sponsor ID
- PRSVH / PRSVH_2019
- Conditions
- Syncytial Virus Respiratory Infection, RSV Infection, Respiratory Syncytial Virus Infections, RSV Bronchiolitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 30 Oct 2019 (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.
The VRS (Respiratory Syncytial Virus) study group in Lyon is a working that aims to understand, predict and prevent the burden of disease caused by human respiratory syncytial virus (RSV) infection in infants. Incidence of RSV-associated hospitalization in the first year of life was estimated at 14.5 (95% CI 13.4-15.6) per 1000 births in a cohort study in Lyon, France. Related direct medical annual costs were estimated for this cohort at 364,269€, mostly attributed to children born during the RSV season (231,959€) and children born premature (108,673€). This study will combine existing hospital specimens and databases to determine the respective role of socio demographic factors, clinical risk factors, level of cord specific antibody at birth, and virus characteristic in the Respiratory Syncytial Virus (RSV) Hospitalization outcome in Infants.
Regarding the introduction of a new RSV vaccine and RSV-specific neutralizing antibodies, these data are of prime importance to guide future vaccine policies.
Detailed description
Objective:
To determine the main predictors of Respiratory Syncytial Virus (RSV) Hospitalizations in Infants
Study design:
Prospective epidemiological, observational, one-center cohort study with sample collection.
Study population:
Birth cohort of infants born in Lyon before and during the RSV circulation period (October to march) with a follow-up until one year old (from birth until the age of 1 year maximum):
- Estimate Birth cohort (n=5,000).
- Estimate number of RSVH case (n=110).
- Estimate number of Blood cordon associated with a RSVH (Respiratory Syncytial Virus Human) case (n=60)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Passive Birth Cohort | – | Other: Not applicable (no intervention)This will be a multicenter, prospective, observational cohort study conducted across the Lyon Public hospital maternity (HFME : Hospital for women, mother and children, Croix-Rousse, Lyon-Sud) recruited from the general population. Infants born between October 2019 and march 2020. At birth the remains (after diagnosis use) of cord blood samples will be store. Groups of RSVh cases and control will be class at one year of age using the hospital data (RSV must be confirmed by RT-PCR). Parents will be informed of the protocol. If enrolled available hospital data will be use and RSV serology testing perform on the store blood cordon. |
Who may qualify
- Ages
- 1 day to 4 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Birth cohort of 5 000 infants of the general population recruited from the HCL (Public hospital of Lyon) maternity wards during the first days after birth
Key inclusion criteria (2 listed)
- Children born alive at participating centers.
- Parents living in the Rhone Alpes Auvergne region
Key exclusion criteria (2 listed)
- Parents non-willing to participate
- Parents living outside the region
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 |
|---|---|---|
| Not applicable (no intervention)Not applicable (no intervention) | Other | Passive Birth Cohort |
Primary outcome
Number of cases included in the cohort with RT-PCR (Retrotranscription) confirmed RSV hospitalization occurring from birth until the age of 1 year
Time frame: 1 year after inclusion
Cases were defined as a new admission to one of the conventional pediatric hospital departments with a RSV positive sample during the hospital stay the first 3 years of life.
Number of cases included in the cohort with RT-PCR confirmed RSV hospitalization occurring from birth until the age of 3 years.
Time frame: 3 years after inclusion
Cases were defined as a new admission to one of the conventional pediatric hospital departments with a RSV positive sample during the hospital stay the first 3 years of life.
2 secondary outcomes
Quantitative level of anti-RSV IgG measure
Time frame: 3 years after inclusion
Quantitative level of anti-RSV IgG (Immunoglobulin G) measure
Time frame: 3 years after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Syncytial Virus Respiratory Infection and RSV Infection, run by Hospices Civils de Lyon.
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 2 inclusion and 2 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 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Jean-Sebastien CASALEGNO, MD/PhD (4 72 07 10 23 ext. +33, jean-sebastien.casalegno@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cases included in the cohort with RT-PCR (Retrotranscription) confirmed RSV hospitalization occurring from birth until the age of 1 year (time frame: 1 year after inclusion). 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?
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 30 Oct 2019.