Respiratory Syncytial Virus (RSV), Palivizumab, respiratoir syncytieel virus (RSV)
Conditions
Interventions
1 nose drop per nostril once daily of palivizumab
Sponsors
University Medical Center Utrecht
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total RSV infection during the first year of life | — |
Secondary
| Measure | Time frame |
|---|---|
| RSV hospitalization*, medically-attended RSV infection, any hospitalization, any nonhospitalized 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 adverse events and severe adverse events. *: Key secondary outcome | — |
Contacts
Public ContactLouis Bont
Wilhelmina Children's hospital / UMC Utrecht Postbus 85090
Outcome results
None listed