asal administration of palivizumab toprevent RSV infectio
- Conditions
- Respiratory Syncytial Virus (RSV), Palivizumab, respiratoir syncytieel virus (RSV)
- Registration Number
- NL-OMON23402
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- Not specified
- Target Recruitment
- 348
Inclusion Criteria
Late preterm infants 32-35 weeks gestational age with at least one sibling who are less than 6 months of age at the onset of the RSV season.
Exclusion Criteria
Children with a known cardiac anomaly, Down syndrome or other serious congenital disorders and children who received surfactant treatment are excluded from the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total RSV infection during the first year of life
- Secondary Outcome Measures
Name Time Method RSV hospitalization*, medically-attended RSV infection, any hospitalization, any nonhospitalized<br>RSV infection, any respiratory disease, non-tested medically attended respiratory tract infection (RTI), RSV negative RTI admission, non-tested RTI admission, use of respiratory medication, otitis media, and wheeze in the first year of life. Incidence and total days of RSV-associated ICU stay, mechanical ventilation and supplemental oxygen. Nasal swabs for co-infections by other respiratory pathogens. Safety data on local and systemic<br>adverse events and severe adverse events.<br /><br>*: Key secondary outcome