Condition category
Respiratory
Date applied
12/09/2005
Date assigned
12/09/2005
Last edited
25/08/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr R Boogaard

ORCID ID

Contact details

Erasmus MC Sophia Children's Hospital
Researcher Pediatric Pulmonology Department
Room SB-2666
P.O.Box 2060
Rotterdam
3000 CB
Netherlands
+31 (0)10 4636683
r.boogaard@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR82

Study information

Scientific title

Acronym

Study hypothesis

Nebulised DNase has a decreasing effect on the duration of a hospital admission in
infants admitted with an RSV-bronchiolitis.

Ethics approval

Received from local medical ethics committee

Study design

Multicentre randomised double blind placebo controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Bronchiolitis, RSV-bronchiolitis

Intervention

Twice daily 2.5 mg DNase or placebo during admission.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Length of stay
2. Symptom score

Secondary outcome measures

1. Duration of oxygen supplementation
2. Need for ICU-admission

Overall trial start date

01/01/2006

Overall trial end date

01/04/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

222 (added 25/08/09)

Participant 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

Recruitment start date

01/01/2006

Recruitment end date

01/04/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus MC Sophia Children's Hospital
Rotterdam
3000 CB
Netherlands

Sponsor information

Organisation

Roche Nederland BV (Netherlands)

Sponsor details

Postbus 44
Woerden
3440 AA
Netherlands

Sponsor type

Industry

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Erasmus Medical Centre (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17356094

Publication citations

  1. Results

    Boogaard R, Hulsmann AR, van Veen L, Vaessen-Verberne AA, Yap YN, Sprij AJ, Brinkhorst G, Sibbles B, Hendriks T, Feith SW, Lincke CR, Brandsma AE, Brand PL, Hop WC, de Hoog M, Merkus PJ, Recombinant human deoxyribonuclease in infants with respiratory syncytial virus bronchiolitis., Chest, 2007, 131, 3, 788-795, doi: 10.1378/chest.06-2282.

Additional files

Editorial Notes