Condition category
Respiratory
Date applied
29/11/2005
Date assigned
01/12/2005
Last edited
11/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.star-trial.com

Contact information

Type

Scientific

Primary contact

Dr Job van Woensel

ORCID ID

Contact details

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

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 measures

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

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

http://www.amc.nl

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

2 Johannes Foundation, Rotterdam, The Netherlands

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

3 Maarten Kappelle Foundation, Voorburg, The Netherlands

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

4 IVAX Farma B.V. Bodegraven, The Netherlands

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

5 Draeger Medical Netherlands BV Zoetermeer, The Netherlands

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

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

Results - basic reporting

Publication summary

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21460709

Publication citations

  1. 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.

Additional files

Editorial Notes