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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ISRCTN
Last refreshed on:	30 August 2021
Main ID:	ISRCTN54608329
Date of registration:	20/12/2005
Prospective Registration:	No
Primary sponsor:	VU University Medical Centre (The Netherlands)
Public title:	Effect of dexamethason on the incidence of detubation failure in children
Scientific title:	Effect of dexamethason on the incidence of detubation failure in children
Date of first enrolment:	01/01/2004
Target sample size:	157
Recruitment status:	Completed
URL:	https://www.isrctn.com/ISRCTN54608329
Study type:	Interventional
Study design:	Randomised, placebo controlled, parallel group, double blinded multicentre trial (Treatment)
Phase:	Not Specified

Countries of recruitment
Netherlands

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	M. van Heerde
Address:	Fellow of pediatric intensive care VU University Medical Centre P.O. Box 7057 1007 MB Amsterdam Netherlands
Telephone:	+31 (0)20 444 4426/3000
Email:	m.vanheerde@vumc.nl
Affiliation:

Key inclusion & exclusion criteria

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

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

Age minimum:
Age maximum:
Gender: Not Specified

Health Condition(s) or Problem(s) studied

Mechanical ventilation, complications
Respiratory
Ventilation

Intervention(s)

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%)

Primary Outcome(s)

Detubation failure

Secondary Outcome(s)

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

Secondary ID(s)

N/A

Source(s) of Monetary Support

Not provided at time of registration

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Ethics approval received from the local medical ethics committee

Results

Results available:	Yes
Date Posted:
Date Completed:	01/04/2006
URL:

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