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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
129
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.
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
Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Istanbul, Turkey (Türkiye)
PRAM (Pediatric Respiratory Assessment Measure) Score at 4th Hour
The PRAM score is a validated clinical scoring system used to assess asthma severity in children. It evaluates clinical signs including suprasternal retractions, scalene muscle contraction, air entry, wheezing, and O2 saturation. The total score ranges from 0 to 12, with higher scores indicating more severe respiratory distress.
Time frame: At 4 hours after the initiation of treatment in the emergency department.
PRAM Score on the 2nd Day Post-Discharge
The PRAM score will be calculated to assess the patient's respiratory status during the follow-up visit. The total score ranges from 0 to 12, with higher scores indicating more severe respiratory distress.
Time frame: 2 days after discharge from the hospital
Total Number of Salbutamol Doses
The total number of short-acting beta-agonist (salbutamol) doses required by the patient after discharge.
Time frame: Up to 14 days post-discharge.
Hospitalization Rate
The percentage of patients who require admission to the pediatric allergy ward or intensive care unit due to inadequate response to emergency treatment.
Time frame: Up to 4 hours post-treatment initiation in the emergency department.
Length of Hospital Stay
The total duration the patient remains in the hospital (emergency department, ward, or ICU) from admission to discharge.
Time frame: From hospital admission to hospital discharge (an expected average of 2 to 5 days)
Rate of Re-presentation to the Hospital
The percentage of patients who return to the emergency department or outpatient clinic with a new or worsened asthma exacerbation.
Time frame: Within 14 days post-discharge
Re-hospitalization Rate
The percentage of patients who require a new hospital admission due to asthma exacerbation after their initial discharge.
Time frame: Within 14 days post-discharge
Incidence of Adverse Events
The number of participants experiencing corticosteroid-related adverse events, including vomiting, hyperglycemia, gastrointestinal bleeding, and hypertension.
Time frame: Up to 14 days post-discharge
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