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Nasal administration of palivizumab to prevent RSV infection


- candidate number29257
- NTR NumberNTR7403
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-jul-2018
- Secondary IDsNL66735.041.18 
- Public TitleNasal administration of palivizumab to prevent RSV infection
- Scientific TitleEffect of local administration of palivizumab on prevention of RSV infection
- ACRONYMNarsyn
- hypothesisNasal administration of palivizumab in late preterm infants reduces RSV infection
- Healt Condition(s) or Problem(s) studiedPalivizumab, Respiratory Syncytial Virus (RSV)
- Inclusion criteriaLate 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 criteriaChildren with a known cardiac anomaly, Down syndrome or other serious congenital disorders and children who received surfactant treatment are excluded from the study.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingTriple
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-nov-2018
- planned closingdate30-apr-2020
- Target number of participants348
- Interventions1 nose drop per nostril once daily of palivizumab
- Primary outcomeTotal RSV infection during the first year of life
- Secondary outcomeRSV 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
- TimepointsContinuous monitoring for RSV infections from October 1 to April 30
- Trial web site
- statusrecruitement status not public
- CONTACT FOR PUBLIC QUERIESDr. Louis Bont
- CONTACT for SCIENTIFIC QUERIESDr. Louis Bont
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
Investigator initiated trial ( IIT )
- Publications
- Brief summaryThis 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.
- Main changes (audit trail)
- RECORD12-jul-2018 - 16-aug-2018


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