Status Asthmaticus, Asthma (Diagnosis), Asthma Exacerbations
Conditions
Keywords
PRAM score, Severe Asthma Exacerbation, Acute Asthma, Dexamethasone, Methylprednisolone
Brief 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.
Interventions
DRUGIntravenous 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.
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
Istanbul Medeniyet University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PRAM (Pediatric Respiratory Assessment Measure) Score at 4th Hour | At 4 hours after the initiation of treatment in the emergency department. | 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. |
| PRAM Score on the 2nd Day Post-Discharge | 2 days after discharge from the hospital | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Salbutamol Doses | Up to 14 days post-discharge. | The total number of short-acting beta-agonist (salbutamol) doses required by the patient after discharge. |
| Hospitalization Rate | Up to 4 hours post-treatment initiation in the emergency department. | The percentage of patients who require admission to the pediatric allergy ward or intensive care unit due to inadequate response to emergency treatment. |
| Length of Hospital Stay | From hospital admission to hospital discharge (an expected average of 2 to 5 days) | The total duration the patient remains in the hospital (emergency department, ward, or ICU) from admission to discharge. |
| Rate of Re-presentation to the Hospital | Within 14 days post-discharge | The percentage of patients who return to the emergency department or outpatient clinic with a new or worsened asthma exacerbation. |
| Re-hospitalization Rate | Within 14 days post-discharge | The percentage of patients who require a new hospital admission due to asthma exacerbation after their initial discharge. |
| Incidence of Adverse Events | Up to 14 days post-discharge | The number of participants experiencing corticosteroid-related adverse events, including vomiting, hyperglycemia, gastrointestinal bleeding, and hypertension. |
Countries
Turkey (Türkiye)
Outcome results
None listed