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IV DEXAMETHASONE VS. METHYLPREDNISOLONE IN CHILDREN WITH SEVERE ASTHMA EXACERBATION

NCT07731217 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2026-07-28

No results posted yet for this study

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.

Conditions

  • Status Asthmaticus
  • Asthma (Diagnosis)
  • Asthma Exacerbations

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

Sponsors & Collaborators

  • Istanbul Medeniyet University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-07-01
Completion
2026-07-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07731217 on ClinicalTrials.gov