Condition category
Respiratory
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
02/03/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M. van Heerde

ORCID ID

Contact details

Fellow of pediatric intensive care
VU University Medical Centre
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 444 4426/3000
m.vanheerde@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Dexamethason reduces the rate of detubation failure in children at risk.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised, placebo controlled, parallel group, double blinded multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Mechanical ventilation, complications

Intervention

Intervention: Dexamethason 6 x 0.5 mg/kg intravenous (i.v.) every six hours (max 10 mg dose) first dose six to 12 hours prior to detubation.
Placebo: Saline (NaCl 0.9%)

Intervention type

Drug

Phase

Not Specified

Drug names

Dexamethason

Primary outcome measures

Detubation failure

Secondary outcome measures

1. Use of other therapies to reduce upper airway obstruction (epinephrin, beclomethasone)
2. Croup score
3. Supplemental oxygen
4. Adverse effects of dexamethason: hypertension, gastro-intestinal tract bleeding, hyperglycaemia

Overall trial start date

01/01/2004

Overall trial end date

01/04/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged four weeks to four years
2. Intubated more than 24 hours
3. Informed consent

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

157

Participant exclusion criteria

1. Known with one of the following diseases:
a. peptic ulcurs
b. diabetes mellitus
c. osteoporosis
d. adrenal insufficiency
e. hypertension
f. systemic yeast infection
g. tuberculosis
h. sepsis
2. Glucocorticoid use the week before detubation
3. Intubation for laryngotracheal infection
4. Mechanical ventilation for upper airway obstruction
5. Down syndrome

Recruitment start date

01/01/2004

Recruitment end date

01/04/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Fellow of pediatric intensive care
Amsterdam
1007 MB
Netherlands

Sponsor information

Organisation

VU University Medical Centre (The Netherlands)

Sponsor details

Department of Paediatrics/Neonatology
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands
+31 (0)20 444 4444
w.fetter@vumc.nl

Sponsor type

University/education

Website

http://www.vumc.nl/english/

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

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

Publication citations

Additional files

Editorial Notes