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
Secondary identifying numbers Protocol 5/5
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

Study website

Contact information

Dr Job van Woensel
Scientific

Pediatric Intensive Care Unit G8ZW
Emma Children's Hospital/AMC
Amsterdam
1100 DD
Netherlands

Study information

Study designMulticenter double-blind randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymSTAR-trial
Study objectivesDoes 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) studiedRespiratory syncytial virus lower respiratory tract infection
InterventionDexamethasone 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Dexamethasone
Primary outcome measureDuration of mechanical ventilation
Secondary outcome measures1. Length of stay in paediatric intensive care unit (PICU)
2. Length of stay in hospital
3. Duration of supplemental oxygen therapy
Overall study start date01/11/2003
Completion date01/04/2007

Eligibility

Participant type(s)Patient
Age groupChild
Upper age limit2 Years
SexBoth
Target number of participants230
Key inclusion criteria1. Children younger than 2 years of age
2. Microbiologically proven RSV lower respiratory tract infection
3. Mechanical ventilation
Key exclusion criteria1. Corticosteroid use within 2 weeks before inclusion
2. No informed consent from parents or caretakers
Date of first enrolment01/11/2003
Date of final enrolment01/04/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Pediatric Intensive Care Unit G8ZW
Amsterdam
1100 DD
Netherlands

Sponsor information

Academic Medical Center (The Netherlands)
University/education

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone +31 (0)20 5669111
Email ic.kinderen@amc.nl
Website http://www.amc.nl
ROR logo "ROR" https://ror.org/03t4gr691

Funders

Funder type

Industry

Main source: Academic Medical Center, Amsterdam, The Netherlands

No information available

Secondary sources:

No information available

1 Van Reekum - van Moorselaar foundation, Amsterdam, The Netherlands

No information available

2 Johannes Foundation, Rotterdam, The Netherlands

No information available

3 Maarten Kappelle Foundation, Voorburg, The Netherlands

No information available

4 IVAX Farma B.V. Bodegraven, The Netherlands

No information available

5 Draeger Medical Netherlands BV Zoetermeer, The Netherlands

No information available

6 Arrow Holland Medical Products B.V. Weesp, The Netherlands

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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