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The efficacy of dexamethasone in mechanically ventilated children with lower respiratory tract infection caused by respiratory syncytial virus (RSV)
DOI 10.1186/ISRCTN13421709
ClinicalTrials.gov identifier
EudraCT number
Public title The efficacy of dexamethasone in mechanically ventilated children with lower respiratory tract infection caused by respiratory syncytial virus (RSV)
Scientific title
Acronym STAR-trial
Serial number at source Protocol 5/5
Study hypothesis Does dexamethasone shorten the duration of mechanical ventilation in children with RSV lower respiratory tract infection?
Lay summary Not provided at time of registration
Ethics approval Approved Medical Ethics Committee, Academic Medical Center, Amsterdam, The Netherlands. Date of approval: 24/11/2003. Reference number: MEC 03/079 # 03.17.0538c.
Study design Multicenter double-blind randomised controlled trial
Countries of recruitment Netherlands
Disease/condition/study domain Respiratory syncytial virus lower respiratory tract infection
Participants - inclusion criteria 1. Children younger than 2 years of age
2. Microbiologically proven RSV lower respiratory tract infection
3. Mechanical ventilation
Participants - exclusion criteria 1. Corticosteroid use within 2 weeks before inclusion
2. No informed consent from parents or caretakers
Anticipated start date 01/11/2003
Anticipated end date 01/04/2007
Status of trial Completed
Patient information material
Target number of participants 230
Interventions 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 measure(s) Duration of mechanical ventilation
Secondary outcome measure(s) 1. Length of stay in paediatric intensive care unit (PICU)
2. Length of stay in hospital
3. Duration of supplemental oxygen therapy
Sources of funding 1. Main source: Academic Medical Center, Amsterdam, The Netherlands
2. Secondary sources:
2.1 Van Reekum - van Moorselaar foundation, Amsterdam, The Netherlands
2.2 Johannes Foundation, Rotterdam, The Netherlands
2.3 Maarten Kappelle Foundation, Voorburg, The Netherlands
2.4 IVAX Farma B.V. Bodegraven, The Netherlands
2.5 Draeger Medical Netherlands BV Zoetermeer, The Netherlands
2.6 Arrow Holland Medical Products B.V. Weesp, The Netherlands
Trial website http://www.star-trial.com
Publications 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21460709
Contact name Dr  Job  van Woensel
  Address Pediatric Intensive Care Unit G8ZW
Emma Children's Hospital/AMC
  City/town Amsterdam
  Zip/Postcode 1100 DD
  Country Netherlands
Sponsor Academic Medical Center (The Netherlands)
  Address P.O. Box 22660
  City/town Amsterdam
  Zip/Postcode 1100 DD
  Country Netherlands
  Tel +31 (0)20 5669111
  Email ic.kinderen@amc.nl
  Sponsor website: http://www.amc.nl
Date applied 29/11/2005
Last edited 11/10/2011
Date ISRCTN assigned 01/12/2005
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