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Effect of dexamethason on the incidence of detubation failure in children.


- candidate number1232
- NTR NumberNTR141
- ISRCTNISRCTN54608329
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR24-aug-2005
- Secondary IDsN/A 
- Public TitleEffect of dexamethason on the incidence of detubation failure in children.
- Scientific TitleEffect of dexamethason on the incidence of detubation failure in children: a double blind placebo controlled multi center trial.
- ACRONYMN/A
- hypothesisDexamethason reduces the rate of detubation failure in children at risk.
- Healt Condition(s) or Problem(s) studiedMechanical ventilation, complications
- Inclusion criteria1. Age 4 weeks - 4 years;
2. Intubated > 24 hours;
3. Informed consent.
- Exclusion criteria1. Known with one of the following diseases:
a. peptic ulcus;
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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2004
- planned closingdate1-apr-2006
- Target number of participants157
- InterventionsDexamethason 6 x 0,5 mg/kg i.v. 6 uur (max 10 mg dose) first dose 6 - 12 hours prior to detubation.
Placebo: Saline (NaCl 0,9%).
- Primary outcomeDetubation failure.
- Secondary outcome1. Use of other therapies to reduce upper airway obstruction (epinephrin, beclomethasone);
2. Croup score;
3. Supplemental oxygen;
4. Adverse effects of dexamethason: hypertension, Gatro-intestinal tract bleeding, hyperglycaemia.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. M. Heerde, van
- CONTACT for SCIENTIFIC QUERIESMD. M. Heerde, van
- Sponsor/Initiator VU University Medical Center, Department of Paediatrics and Neonatology
- Funding
(Source(s) of Monetary or Material Support)
None
- PublicationsN/A
- Brief summaryUpper airway obstrection is frequently seen (30%) after detubation in children at risk (4 weeks-4years, and prolonged intabation > 24 hours). There is often a need for reintubation (5%). Dexamethason may reduce the the frequency of upper airway obstruction and the need for reintubation. This has been studied earlier, however there is a lack of properly designed studies.
- Main changes (audit trail)
- RECORD17-aug-2005 - 11-nov-2008


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