Efficacy of inhaled DNase in admitted infants with RSV-bronchiolitis
| ISRCTN | ISRCTN92577199 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92577199 |
| Secondary identifying numbers | NTR82 |
- Submission date
- 12/09/2005
- Registration date
- 12/09/2005
- Last edited
- 25/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr R Boogaard
Scientific
Scientific
Erasmus MC Sophia Children's Hospital
Researcher Pediatric Pulmonology Department
Room SB-2666
P.O.Box 2060
Rotterdam
3000 CB
Netherlands
| Phone | +31 (0)10 4636683 |
|---|---|
| r.boogaard@erasmusmc.nl |
Study information
| Study design | Multicentre randomised double blind placebo controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Nebulised DNase has a decreasing effect on the duration of a hospital admission in infants admitted with an RSV-bronchiolitis. |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Bronchiolitis, RSV-bronchiolitis |
| Intervention | Twice daily 2.5 mg DNase or placebo during admission. |
| Intervention type | Other |
| Primary outcome measure | 1. Length of stay 2. Symptom score |
| Secondary outcome measures | 1. Duration of oxygen supplementation 2. Need for ICU-admission |
| Overall study start date | 01/01/2006 |
| Completion date | 01/04/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target number of participants | 222 (added 25/08/09) |
| Key inclusion criteria | 1. RSV bronchiolitis with need for additional oxygen (saturation iÜ 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 |
| Key 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 |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 01/04/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus MC Sophia Children's Hospital
Rotterdam
3000 CB
Netherlands
3000 CB
Netherlands
Sponsor information
Roche Nederland BV (Netherlands)
Industry
Industry
Postbus 44
Woerden
3440 AA
Netherlands
"ROR" |
https://ror.org/01gcg9888 |
|---|
Funders
Funder type
Hospital/treatment centre
Erasmus Medical Centre (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2007 | Yes | No |
