|
Main
|
|
Note: This record shows only 22 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. |
|
Register:
|
ISRCTN |
|
Last refreshed on:
|
13 January 2015 |
|
Main ID: |
ISRCTN13421709 |
|
Date of registration:
|
01/12/2005 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
The efficacy of dexamethasone in mechanically ventilated children with lower respiratory tract infection caused by respiratory syncytial virus (RSV)
|
|
Scientific title:
|
|
|
Date of first enrolment:
|
01/11/2003 |
|
Target sample size:
|
230 |
|
Recruitment status: |
Completed |
|
URL:
|
http://isrctn.com/ISRCTN13421709 |
|
Study type:
|
Interventional |
|
Study design:
|
Multicenter double-blind randomised controlled trial (Treatment)
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Netherlands
| | | | | | | |
|
Contacts
|
|
Name:
|
Job
van Woensel |
|
Address:
|
Pediatric Intensive Care Unit G8ZW
Emma Children's Hospital/AMC
1100 DD
Amsterdam
Netherlands |
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 1. Children younger than 2 years of age
2. Microbiologically proven RSV lower respiratory tract infection
3. Mechanical ventilation
Exclusion criteria: 1. Corticosteroid use within 2 weeks before inclusion
2. No informed consent from parents or caretakers
Age minimum:
Age maximum:
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
Respiratory syncytial virus lower respiratory tract infection
Respiratory
Respiratory syncytial virus
|
|
Intervention(s)
|
Dexamethasone 0.15 mg/kg/dose every 6 hours, 8 doses in total (i.e. 2 days) or placebo (normal saline)
2004 protocol version 5/5 in http://www.star-trial.com/files/STARprotocol_aug04.pdf
|
|
Primary Outcome(s)
|
|
Duration of mechanical ventilation
|
|
Secondary Outcome(s)
|
1. Length of stay in paediatric intensive care unit (PICU)
2. Length of stay in hospital
3. Duration of supplemental oxygen therapy
|
|
Secondary ID(s)
|
|
Protocol 5/5
|
|
Source(s) of Monetary Support
|
|
Main source: Academic Medical Center, Amsterdam, The Netherlands, Secondary sources:, 1 Van Reekum - van Moorselaar foundation, Amsterdam, The Netherlands, 2 Johannes Foundation, Rotterdam, The Netherlands, 3 Maarten Kappelle Foundation, Voorburg, The Netherlands, 4 IVAX Farma B.V. Bodegraven, The Netherlands, 5 Draeger Medical Netherlands BV Zoetermeer, The Netherlands, 6 Arrow Holland Medical Products B.V. Weesp, The Netherlands
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|