← Back to all trials
Completed
NCT07731217
IV DEXAMETHASONE VS. METHYLPREDNISOLONE IN CHILDREN WITH SEVERE ASTHMA EXACERBATION
Conditions: Status Asthmaticus, Asthma (Diagnosis), Asthma Exacerbations
Sex: All
Ages: 2 Years – 18 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 129
Sponsor: Istanbul Medeniyet University
Location: Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital Istanbul
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.
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).
\-
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.
\-
Source: ClinicalTrials.gov (NCT07731217). StuddyBuddy aggregates publicly available trial information.