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Pediatric Asthma Trial of Corticosteroid Heterogeneity (PATCH): Trial of Dexamethasone Versus Methylprednisolone for Pediatric Critical Asthma

NCT07455396

Not Yet RecruitingPhase 2

Sponsor: Johns Hopkins All Children's Hospital

Conditions: Asthma (Diagnosis)

Interventions: Dexamethasone (0.6mg/kg; Max 16mg) Once Daily, Dexamethasone (0.25 mg/kg/dose, Max dose 16mg) every 6-hours, Methylprednisolone

Countries: United States

Acute asthma exacerbation is caused by dysregulated pulmonary inflammatory pathways such that standard treatment includes prompt administration of exogenous systemic corticosteroids (SCs), but there remains an ongoing dialogue among the expert medical community regarding the superiority of specific SCs including dose, frequency of administration, route, and delivery. Regimens are often chosen based on provider preference, and different strategies include once-daily dosing (ODD) dexamethasone (DM) 0.6 mg/kg/dose for 2 days, every 6 hours (q6h) DM 0.25 mg/kg/dose for 2 days, and methylprednisolone (MP) 1 mg/kg/dose every 6 hours for 5-days. To address this knowledge gap, the investigators plan to perform a single-center, phase 2, randomized clinical trial of children 3-17 years of age hospitalized for critical asthma (CA) randomized to one of three regimens above. The study would be powered to evaluate rates of additional prescriptions of SC and also secondarily evaluate quality of life metrics.

Eligibility overview

Sex: ALL

Age: 3 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Age 3-17 years
* Intensive care unit admission
* Treatment for critical asthma

Exclusion Criteria:

* History of unrepaired critical congenital heart disease
* History of cystic fibrosis
* Active tracheostomy dependence

Locations (1)

St. Petersburg, Florida, United States