Efficacy of inhaled DNase in admitted infants with RSV-bronchiolitis

ISRCTN	ISRCTN92577199
DOI	https://doi.org/10.1186/ISRCTN92577199
Protocol serial number	NTR82
Sponsor	Roche Nederland BV (Netherlands)
Funder	Erasmus Medical Centre (Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr R Boogaard
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
Email	r.boogaard@erasmusmc.nl

Primary study design	Interventional
Study design	Multicentre randomised double blind placebo controlled parallel group trial
Secondary study design	Randomised controlled trial
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(s)	1. Length of stay 2. Symptom score
Key secondary outcome measure(s)	1. Duration of oxygen supplementation 2. Need for ICU-admission
Completion date	01/04/2006

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	222
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

Erasmus MC Sophia Children's Hospital

Rotterdam
3000 CB
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2007		Yes	No