Ideal Steroids for Asthma Treatment in the PICU
Condition: Asthma Childhood
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      Determine if differences in (1) pediatric intensive care unit length of stay, (2) continuous
      nebulized albuterol duration, and (3) a composite outcome of advanced asthma therapy
      incidence including use of non-invasive ventilation (NIV), terbutaline, inhaled helium and
      mechanical ventilation between cohorts of children admitted with status asthmaticus to the
      PICU treated with either IV dexamethasone (DM) or methylprednisolone (MP).
    

Detailed description: 
      As the pathophysiology of an acute asthma exacerbation is dysregulated inflammatory pathways,
      standard treatment includes the prompt initiation of intravenous systemic corticosteroids.
      Corticosteroids reduce the production of many mediators involved in the inflammatory process
      and inhibit macrophages, monocytes, T-lymphocytes, eosinophils, and basophils, which are
      activated during this process. Furthermore, corticosteroids improve the efficacy of beta-2
      agonists, such as albuterol, a nebulized medication used for bronchodilation in acute asthma
      exacerbations. There remains an ongoing dialogue among the expert medical community regarding
      the superiority of specific IV corticosteroid, dosing, route and delivery. This debate
      continues secondary to a lack of definitive comparative data in the literature. While the
      benefits of receiving systemic corticosteroids has been demonstrated in multiple studies, to
      date, no head-to-head trials have been conducted comparing IV systemic corticosteroids in the
      PICU setting (DM vs. MP).

      While several systemic corticosteroids are FDA approved for the treatment of asthma
      exacerbation including prednisone, prednisolone, MP and DM, the standard practice in
      PICU-level care is IV MP every 6 hours until enteral medications can be safely tolerated.
      Recent data from emergency room literature would suggest there is equipoise in use of
      dexamethasone as an alternative for methylprednisolone due to its increased glucocorticoid
      (anti-inflammatory) potency. Steroid agents are chosen at the discretion of clinical
      providers based upon a child's capacity to tolerate enteral medications and the specific
      clinical setting (outpatient vs. general inpatient vs. critical inpatient).

      The investigators have performed a retrospective study over a 2-year period to assess if
      differences in clinical outcomes or adverse events exist in cohorts defined by DM exposure in
      the ER. Their data revealed no differences, but most children were switched to MP during
      their PICU stay making data analyses severely confounded by exposure to the defining
      characteristics of the comparative cohort. The investigators seek to first prospectively
      consent individuals to receive DM during their PICU asthma treatment and compare outcomes to
      PICU asthmatics concurrently admitted to the PICU receiving local standard care (MP). Johns
      Hopkins All Children's Hospital (JHACH) admits approximately 150 asthmatics per year in the
      PICU and the investigators hope to enroll up to 50 subjects into a DM only arm. The
      comparative standard care arm will be assessed at the end of the study period. Primary
      outcomes include (1) PICU Length of Stay, (2) Continuous nebulized albuterol duration, and
      (3) a composite outcome including use of non-invasive ventilation (NIV), terbutaline, inhaled
      helium, inhaled anesthetic gas, mechanical ventilation, and extracorporeal life support. This
      research will provide the needed epidemiologic and basic comparative data required to power
      and conduct a definitive, head-to-head trial of DM vs. MP.
    

Intervention name(s): Dexamethasone
Intervention type(s): Drug
Intervention description(s): Non-randomized, open-label, prospective use of intravenous dexamethasone for children admitted to the PICU with status asthmaticus
Intervention MeSH terms: Dexamethasone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Single Arm Treatment Group with a Prospective, Comparative Cohort Receiving Standard Care
Masking: None (Open Label)
Primary purpose: Treatment