Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effect of dexamethason on the incidence of detubation failure in children
Acronym
Study hypothesis
Dexamethason reduces the rate of detubation failure in children at risk.
Ethics approval(s)
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
Study setting(s)
Not specified
Study 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
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Dexamethason
Primary outcome measure
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 study start date
01/01/2004
Overall study end date
01/04/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged four weeks to four years
2. Intubated more than 24 hours
3. Informed consent
Participant type(s)
Patient
Age group
Child
Lower age limit
4 Weeks
Upper age limit
4 Years
Sex
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
Study 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
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|