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Efficacy of inhaled DNase in admitted infants with RSV-bronchiolitis.


- candidate number0
- NTR NumberNTR82
- ISRCTNISRCTN92577199
- Date ISRCTN created12-sep-2005
- date ISRCTN requested15-aug-2005
- Date Registered NTR4-jul-2005
- Secondary IDsN/A 
- Public TitleEfficacy of inhaled DNase in admitted infants with RSV-bronchiolitis.
- Scientific TitleEfficacy of inhaled DNase in admitted infants with RSV-bronchiolitis.
- ACRONYMN/A
- hypothesisNebulised DNase has a decreasing effect on the duration of a hospital admission in infants admitted with an RSV-bronchiolitis.
- Healt Condition(s) or Problem(s) studiedRespiratory syncytial virus (RSV) bronchiolitis, Bronchiolitis
- Inclusion criteria1. RSV bronchiolitis with need for additional oxygen (saturation 92 %);
2. RSV-infection proven with rapid assay or culture;
3. Age < 12 months ;
4. Admission on (medium care) ward;
5. Study medication can be started within 24 hours.
- Exclusion criteria1. Premature birth (born < 32 weeks of gestation);
2. Congenital heart disease;
3. Pre-existent lung disease (e.g. BPD or CF);
4. T-cel immune deficiency;
5. Pre-treatment with systemic steroids.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2002
- planned closingdate1-apr-2006
- Target number of participants180
- InterventionsTwice daily 2,5 mg DNase or placebo during admission.
- Primary outcomeLength of stay and symptom score.
- Secondary outcomeDuration of oxygen suppletion, need for ICU-admission.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD. R. Boogaard
- CONTACT for SCIENTIFIC QUERIESMD. R. Boogaard
- Sponsor/Initiator Erasmus Medical Center, Sophia Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
Roche Nederland BV
- PublicationsChest. 2007 Mar;131(3):788-95.
- Brief summaryN/A
- Main changes (audit trail)
- RECORD15-aug-2005 - 11-nov-2008


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