Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Protocol 5/5
Study information
Scientific title
Acronym
STAR-trial
Study hypothesis
Does dexamethasone shorten the duration of mechanical ventilation in children with RSV lower respiratory tract infection?
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
Dexamethasone
Primary outcome measure
Duration of mechanical ventilation
Secondary outcome measures
1. Length of stay in paediatric intensive care unit (PICU)
2. Length of stay in hospital
3. Duration of supplemental oxygen therapy
Overall trial start date
01/11/2003
Overall trial end date
01/04/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Children younger than 2 years of age
2. Microbiologically proven RSV lower respiratory tract infection
3. Mechanical ventilation
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
230
Participant exclusion criteria
1. Corticosteroid use within 2 weeks before inclusion
2. No informed consent from parents or caretakers
Recruitment start date
01/11/2003
Recruitment end date
01/04/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Pediatric Intensive Care Unit G8ZW
Amsterdam
1100 DD
Netherlands
Sponsor information
Organisation
Academic Medical Center (The Netherlands)
Sponsor details
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 5669111
ic.kinderen@amc.nl
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Main source: Academic Medical Center, Amsterdam, The Netherlands
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Secondary sources:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
1 Van Reekum - van Moorselaar foundation, Amsterdam, The Netherlands
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Location
Funder name
2 Johannes Foundation, Rotterdam, The Netherlands
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Location
Funder name
3 Maarten Kappelle Foundation, Voorburg, The Netherlands
Alternative name(s)
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Location
Funder name
4 IVAX Farma B.V. Bodegraven, The Netherlands
Alternative name(s)
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Funder name
5 Draeger Medical Netherlands BV Zoetermeer, The Netherlands
Alternative name(s)
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Location
Funder name
6 Arrow Holland Medical Products B.V. Weesp, The Netherlands
Alternative name(s)
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Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21460709
Publication citations
-
Results
van Woensel JB, Vyas H, , Dexamethasone in children mechanically ventilated for lower respiratory tract infection caused by respiratory syncytial virus: a randomized controlled trial., Crit. Care Med., 2011, 39, 7, 1779-1783, doi: 10.1097/CCM.0b013e318218a030.