The efficacy of dexamethasone in mechanically ventilated children with lower respiratory tract infection caused by respiratory syncytial virus (RSV)
| ISRCTN | ISRCTN13421709 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13421709 |
| Protocol serial number | Protocol 5/5 |
| Sponsor | Academic Medical Center (The Netherlands) |
| Funders | 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 |
- Submission date
- 29/11/2005
- Registration date
- 01/12/2005
- Last edited
- 11/10/2011
- 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 Job van Woensel
Scientific
Scientific
Pediatric Intensive Care Unit G8ZW
Emma Children's Hospital/AMC
Amsterdam
1100 DD
Netherlands
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicenter double-blind randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | STAR-trial |
| Study objectives | Does dexamethasone shorten the duration of mechanical ventilation in children with RSV lower respiratory tract infection? |
| Ethics approval(s) | Approved Medical Ethics Committee, Academic Medical Center, Amsterdam, The Netherlands. Date of approval: 24/11/2003. Reference number: MEC 03/079 # 03.17.0538c. |
| Health condition(s) or problem(s) studied | Respiratory syncytial virus lower respiratory tract infection |
| Intervention | 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 |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Dexamethasone |
| Primary outcome measure(s) |
Duration of mechanical ventilation |
| Key secondary outcome measure(s) |
1. Length of stay in paediatric intensive care unit (PICU) |
| Completion date | 01/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 2 Years |
| Sex | All |
| Target sample size at registration | 230 |
| Key inclusion criteria | 1. Children younger than 2 years of age 2. Microbiologically proven RSV lower respiratory tract infection 3. Mechanical ventilation |
| Key exclusion criteria | 1. Corticosteroid use within 2 weeks before inclusion 2. No informed consent from parents or caretakers |
| Date of first enrolment | 01/11/2003 |
| Date of final enrolment | 01/04/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Pediatric Intensive Care Unit G8ZW
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/07/2011 | Yes | No | |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
