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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR82 |
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Date of registration:
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04/07/2005 |
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Primary sponsor: |
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Public title:
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Efficacy of inhaled DNase in admitted infants with RSV-bronchiolitis.
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Scientific title:
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Efficacy of inhaled DNase in admitted infants with RSV-bronchiolitis. - N/A |
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Date of first enrolment:
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1/12/2002 |
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Target sample size:
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180 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=82 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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R.
Boogaard |
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Address:
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Erasmus Medical Center, Sophia Children?s Hospital, Department of Pediatric Pulmonology, SB-2666,
P.O. Box 2060
3000 CB
Rotterdam
The Netherlands |
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Telephone:
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+31 (0)10 4636683 |
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Email:
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r.boogaard@erasmusmc.nl |
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Affiliation:
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Name:
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R.
Boogaard |
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Address:
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Erasmus Medical Center, Sophia Children?s Hospital, Department of Pediatric Pulmonology, SB-2666,
P.O. Box 2060
3000 CB
Rotterdam
The Netherlands |
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Telephone:
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+31 (0)10 4636683 |
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Email:
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r.boogaard@erasmusmc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Respiratory syncytial virus (RSV) bronchiolitis, Bronchiolitis
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Intervention(s)
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Twice daily 2,5 mg DNase or placebo during admission.
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Primary Outcome(s)
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Length of stay and symptom score.
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Secondary Outcome(s)
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Duration of oxygen suppletion, need
for ICU-admission.
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Secondary ID(s)
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ISRCTN92577199
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N/A
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Source(s) of Monetary Support
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Roche Nederland BV
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