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

Effect of dexamethason on the incidence of detubation failure in children: a double blind placebo controlled multi center trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28763

Enrollment

157

Registered

2005-08-24

Start date

2004-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanically ventilated children.

Interventions

Dexamethason 6 x 0,5 mg/kg i.v. à 6 uur (max 10 mg dose) first dose 6 - 12 hours prior to detubation. Placebo: Saline (NaCl 0,9%).

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 4 weeks - 4 years; 2. Intubated > 24 hours; 3. Informed consent.

Exclusion criteria

Exclusion criteria: 1. 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.

Design outcomes

Primary

Measure	Time frame
Detubation failure.	—

Secondary

Measure	Time frame
1. 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.	—

Contacts

Public ContactM. Heerde, van

VU University Medical Center, Department of Pediatric Intensive Care, P.O. Box 7057

m.vanheerde@vumc.nl+31 (0)20 4444426 / +31 (0)20 4443000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)