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COMPLETED
NCT07731217
PHASE4

IV DEXAMETHASONE VS. METHYLPREDNISOLONE IN CHILDREN WITH SEVERE ASTHMA EXACERBATION

Sponsor: Istanbul Medeniyet University

View on ClinicalTrials.gov

Summary

The study aims to determine whether a two-day intravenous course of dexamethasone is non-inferior to a conventional five-day intravenous course of methylprednisolone in children presenting with severe asthma exacerbations. To answer this question, researchers randomly assign eligible children to receive either IV dexamethasone or IV methylprednisolone. The clinical response to the treatments is objectively evaluated and compared using the Pediatric Respiratory Assessment Measure (PRAM) score at the 4th hour of treatment and on the 2nd day following hospital discharge.

Official title: INTRAVENOUS DEXAMETHASONE VERSUS METHYLPREDNISOLONE IN WITH SEVERE ASTHMA EXACERBATION: A RANDOMISED, OPEN-LABEL, SINGLE-CENTRE STUDY

Key Details

Gender

All

Age Range

2 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

129

Start Date

2025-09-01

Completion Date

2026-07-15

Last Updated

2026-07-28

Healthy Volunteers

No

Interventions

DRUG

Intravenous Dexamethasone

Patients assigned to this intervention will receive intravenous dexamethasone at a dosage of 0.6 mg/kg/day. The total daily dose will be divided and administered every 12 hours. The maximum allowable dose is 16 mg/day, and the total duration of this treatment protocol is 2 days. If a patient is discharged from the hospital before the completion of the 2-day steroid protocol, the remaining treatment will be completed orally at home.

DRUG

Intravenous Methylprednisolone

Patients assigned to this intervention will receive intravenous methylprednisolone at a dosage of 2 mg/kg/day. The total daily dose will be divided and administered every 12 hours. The maximum daily dose is age-dependent (30 mg/day for children aged 2-5 years; 60 mg/day for children aged 5-12 years; and 80 mg/day for children aged 12 years and older). The total duration of this standard treatment protocol is 5 days. If a patient is discharged from the hospital before the completion of the 5-day steroid protocol, the remaining treatment will be completed oral

Locations (1)

Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Istanbul, Turkey (Türkiye)