Preventing RSV in infants born in France during the 2024–2025 season
Prevention Strategy for Respiratory Syncytial Virus (RSV) Infections in Infants: Maternal Vaccination During Pregnancy or Direct Immunization of Children? A French Online Study
This questionnaire will see if infants born in metropolitan France between October 1, 2024 and January 31, 2025 are reached by and receive new RSV prevention measures such as nirsevimab or vaccines.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | palivizumab, nirsevimab |
| Locations | 1 site (Paris) |
| Trial ID | NCT06881953 on ClinicalTrials.gov |
What this trial studies
Researchers will use a questionnaire of mothers who deliver term infants in metropolitan France between October 1, 2024 and January 31, 2025 to document which RSV prevention measures their newborns receive and to identify barriers to uptake. Participants must be at least 18 years old, able to read and understand French, have a live term newborn, and not be under legal protection. The observational design collects self-reported data at participating sites including Hôpital Pitié Salpêtrière and public health departments without introducing any interventions. Results will describe national coverage of newer pharmacological options (for example nirsevimab and forthcoming vaccines) alongside existing non-pharmacological measures.
Who should consider this trial
Good fit: Ideal participants are French-speaking women aged 18 or older who give birth to a live, term infant in metropolitan France between October 1, 2024 and January 31, 2025 and do not object to participation.
Not a fit: Women under legal protection, those who give birth before 37 weeks or outside the enrollment dates, or those unable to read French are unlikely to be included or to benefit from this study's findings.
Why it matters
Potential benefit: If successful, the results could help public health teams improve outreach and increase newborn protection against RSV, potentially reducing infant hospitalizations.
How similar studies have performed: Randomized trials have shown that nirsevimab and maternal RSV vaccines can reduce severe RSV in infants, and prior observational surveillance has monitored uptake, but large-scale national coverage data for France in the 2024–25 season remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 * Able to speak and understand French well enough to read and comprehend the information leaflet and the questionnaire * Delivery in metropolitan France between October 1, 2024, and January 31, 2025 * Live-born child * Term-born child (37 weeks of gestation or more) * No objection to participating in the study Exclusion Criteria: * Women under legal protection
Where this trial is running
Paris
- Public health department, Hôpital Pitié Salpêtrière — Paris, France (Recruiting)
Study contacts
- Study coordinator: Bénédicte COULM, RM,PhD
- Email: benedicte.coulm@aphp.fr
- Phone: 01 84 82 85 34
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.