No registrations found.
ID
Source
Brief title
Health condition
Respiratory Syncytial Virus (RSV), Palivizumab, respiratoir syncytieel virus (RSV)
Sponsors and support
Intervention
Outcome measures
Primary outcome
Total RSV infection during the first year of life
Secondary outcome
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
Background summary
This study is a phase IIb double-blind placebo controlled proof-of-concept trial in target
population (healthy late preterm infants). We plan to enroll 348 infants and randomise to receive intranasal palivizumab or placebo nasal drops for 2-5 months. The main study outcome is total RSV infection.
Study objective
Nasal administration of palivizumab in late preterm infants reduces RSV infection
Study design
Continuous monitoring for RSV infections from October 1 to April 30
Intervention
1 nose drop per nostril once daily of palivizumab
Postbus 85090
Louis Bont
Wilhelmina Children's hospital / UMC Utrecht
Department Pediatric Immunology and Infectious Diseases KE.04.133.1
Lundlaan 6
Utrecht 3584 EA
The Netherlands
+31 (0)88 7555555
l.bont@umcutrecht.nl
Postbus 85090
Louis Bont
Wilhelmina Children's hospital / UMC Utrecht
Department Pediatric Immunology and Infectious Diseases KE.04.133.1
Lundlaan 6
Utrecht 3584 EA
The Netherlands
+31 (0)88 7555555
l.bont@umcutrecht.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7204 |
| NTR-old | NTR7403 |
| CCMO | NL66735.041.18 |
| OMON | NL-OMON55390 |