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IV DEXAMETHASONE VS. METHYLPREDNISOLONE IN CHILDREN WITH SEVERE ASTHMA EXACERBATION

CompletedPhase 4

Sponsor: Istanbul Medeniyet University

Conditions: Status Asthmaticus, Asthma (Diagnosis), Asthma Exacerbations

Interventions: Intravenous Dexamethasone, Intravenous Methylprednisolone

Countries: Turkey (Türkiye)

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.

Eligibility overview

Sex: ALL

Age: 2 Years to 18 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:Aged between 2 and 18 years.

History of receiving salbutamol ± steroid treatment for two or more previous wheezing attacks, OR physician-diagnosed asthma.

Patients admitted to the Pediatric Emergency Department due to severe asthma exacerbation (Pediatric Respiratory Assessment Measure \[PRAM\] score ≥8).

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Exclusion Criteria: Patients with suspected or confirmed foreign body aspiration.

Patients with concurrent croup.

Presence of comorbidities (cardiovascular, neurological, malignancy, chronic kidney or lung disease).

Patients with pneumonia.

Patients with air leaks (pneumothorax, pneumomediastinum).

Patients requiring immediate Intensive Care Unit (ICU) admission.

Systemic steroid use within the last 8 weeks.

Failure to obtain informed consent.

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Locations (1)

Istanbul, Turkey (Türkiye)