| - candidate number | 0 |
| - NTR Number | NTR82 |
| - ISRCTN | ISRCTN92577199 |
| - Date ISRCTN created | 12-sep-2005 |
| - date ISRCTN requested | 15-aug-2005 |
| - Date Registered NTR | 4-jul-2005 |
| - Secondary IDs | N/A |
| - Public Title | Efficacy of inhaled DNase in admitted infants with RSV-bronchiolitis. |
| - Scientific Title | Efficacy of inhaled DNase in admitted infants with RSV-bronchiolitis. |
| - ACRONYM | N/A |
| - hypothesis | Nebulised 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) studied | Respiratory syncytial virus (RSV) bronchiolitis, Bronchiolitis |
| - Inclusion criteria | 1. RSV bronchiolitis with need for additional oxygen (saturation ¡Ü 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 criteria | 1. 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 received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Placebo |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-dec-2002 |
| - planned closingdate | 1-apr-2006 |
| - Target number of participants | 180 |
| - Interventions | Twice daily 2,5 mg DNase or placebo during admission. |
| - Primary outcome | Length of stay and symptom score. |
| - Secondary outcome | Duration of oxygen suppletion, need for ICU-admission. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | stopped: trial finished |
| - CONTACT FOR PUBLIC QUERIES | MD. R. Boogaard |
| - CONTACT for SCIENTIFIC QUERIES | MD. R. Boogaard |
| - Sponsor/Initiator | Erasmus Medical Center, Sophia Children's Hospital |
| - Funding (Source(s) of Monetary or Material Support) | Roche Nederland BV |
| - Publications | Chest. 2007 Mar;131(3):788-95. |
| - Brief summary | N/A |
| - Main changes (audit trail) | |
| - RECORD | 15-aug-2005 - 11-nov-2008 |
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