Nasal administration of palivizumab in late preterm infants reduces RSV infection
ID
Bron
Verkorte titel
Aandoening
Respiratory Syncytial Virus (RSV), Palivizumab, respiratoir syncytieel virus (RSV)
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Total RSV infection during the first year of life
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Nasal administration of palivizumab in late preterm infants reduces RSV infection
Onderzoeksopzet
Continuous monitoring for RSV infections from October 1 to April 30
Onderzoeksproduct en/of interventie
1 nose drop per nostril once daily of palivizumab
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Children with a known cardiac anomaly, Down syndrome or other serious congenital disorders and children who received surfactant treatment are excluded from the study.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7204 |
| NTR-old | NTR7403 |
| CCMO | NL66735.041.18 |
| OMON | NL-OMON55390 |