Neonatal Echovirus 11 infections in Italy: virological, genomic and clinical insights
Neonatal Enterovirus Infections in Italy: Virological Characterization, Genomic and Clinical-epidemiological Insights on Echovirus 11
This project will test whether sequencing virus samples from newborns with enterovirus infections, especially Echovirus 11, helps explain how the virus causes illness in the first weeks of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1600 (estimated) |
| Ages | 1 Day to 28 Days |
| Sex | All |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia, Lombardy) |
| Trial ID | NCT07356583 on ClinicalTrials.gov |
What this trial studies
This observational project collects respiratory and residual clinical samples from consecutive neonates admitted to the NICU at Fondazione IRCCS Policlinico San Matteo in Pavia. Samples with sufficient volume (≥1 mL nasal swab) will undergo virological characterization, including next-generation sequencing to obtain viral genomes. Genomic data will be linked with clinical and epidemiological information to identify viral variants, transmission patterns, and associations with severe outcomes such as sepsis, respiratory complications, or gastrointestinal disease. No investigational treatments are given; the work is laboratory and data-driven to improve understanding of neonatal enterovirus infections.
Who should consider this trial
Good fit: Ideal candidates are neonates admitted to the NICU with suspected or confirmed enterovirus infection who have sufficient residual clinical samples (at least 1 mL nasal swab) available for sequencing.
Not a fit: Infants without sufficient sample volume, older children, or neonates without enterovirus infection are unlikely to benefit directly from this observational effort.
Why it matters
Potential benefit: If successful, this work could improve diagnosis, outbreak detection, and infection-control strategies for newborns with enterovirus infections and help guide clinical care.
How similar studies have performed: Genomic surveillance and sequencing of enteroviruses have been successfully used in prior outbreaks, though detailed neonatal-focused genomic data for Echovirus 11 remain relatively limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Samples from consecutive neonates admitted to neonatal intensive care unit. Exclusion Criteria: Insufficient residual samples (volume less than 1 mL of nasal swab) will be excluded from the study
Where this trial is running
Pavia, Lombardy
- Fondazione IRCCS Policlinico San Matteo — Pavia, Lombardy, Italy (Recruiting)
Study contacts
- Study coordinator: Antonio Piralla
- Email: a.piralla@smatteo.pv.it
- Phone: +390382502420
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.