Effect of dexamethason on the incidence of detubation failure in children

ISRCTN	ISRCTN54608329
DOI	https://doi.org/10.1186/ISRCTN54608329
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr M. van Heerde
Scientific

Fellow of pediatric intensive care
VU University Medical Centre
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Phone	+31 (0)20 444 4426/3000
Email	m.vanheerde@vumc.nl

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
Scientific title	Effect of dexamethason on the incidence of detubation failure in children
Study objectives	Dexamethason reduces the rate of detubation failure in children at risk.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	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
Completion date	01/04/2006

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
Key inclusion criteria	1. Aged four weeks to four years 2. Intubated more than 24 hours 3. Informed consent
Key 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
Date of first enrolment	01/01/2004
Date of final enrolment	01/04/2006

Fellow of pediatric intensive care

Amsterdam
1007 MB
Netherlands

VU University Medical Centre (The Netherlands)
University/education

Department of Paediatrics/Neonatology
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands

Not defined

Not provided at time of registration

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

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