Steroid Use in Non-RSV Bronchiolitis
Condition: Bronchiolitis, Viral
MeSH terms: Bronchiolitis; Bronchiolitis, Viral
Intervention: Placebos; Dexamethasone Oral
Intervention description: Sugar water based on same ml dosing of intervention arm drug; 0.6mg/kg/dose - single oral dose administration to intervention arm
Intervention MeSH terms: Dexamethasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to either intervention or control group upon admission if they meet inclusion/exclusion criteria and consent.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3.0
Sex: All
Minimum age: 1 Day
Maximum age: 2 Years
Healthy volunteers: No
Keywords: bronchiolitis; non-RSV bronchiolitis; dexamethasone; treatment; steroid

Summary:

      The proposed study is a pilot randomized control trial to determine the efficacy of
      dexamethasone use in hospitalized children who are less than 2 years of age with
      non-respiratory syncytial virus (RSV) bronchiolitis admitted to the University of Pittsburgh
      Medical Center (UPMC) Children's Hospital of Pittsburgh from February 1 to May 31, 2022. It
      is hypothesized that the use of standard airway-dose steroids (0.6mg/kg dexamethasone) will
      improve the clinical outcome of children hospitalized for non-RSV bronchiolitis, which will
      be evident by decreased length of stay.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Less than or equal to 24 months

          2. First episode of wheezing or first clinical diagnosis of bronchiolitis

          3. Admitted to the general pediatric service at UPMC Children's Hospital of Pittsburgh

          4. Ability of a parent or guardian to understand and comply with the study procedures

          5. Signed written informed consent by parent or guardian

        Exclusion Criteria:

          1. Preterm birth < 35 weeks

          2. Presence of underlying cardiopulmonary, neuromuscular, or other complex disease

          3. Admission to the pediatric intensive care unit

          4. Co-infection with influenza infection or concomitant bacterial infection (such as
             pneumonia or AOM)

          5. History of allergy or reaction to steroids

          6. History of an underlying chronic medical condition -including chronic heart disease,
             chronic lung disease (except asthma),congenital anomalies of the airways or lung,
             cystic fibrosis, chronic renal disease including nephrotic syndrome, protein losing
             enteropathy of any cause, severe malnutrition, neurocognitive disorders, metabolic
             disorders (including phenylketonuria), or genetic disorders (note: genetic syndromes
             such as Down syndrome and Edwards Syndrome are excluded; however, children with
             genetic disorders (e.g., hemophilia) but who do not have a genetic syndrome may not
             satisfy this particular exclusion criterion; it is important that children with such
             genetic disorders do not have symptoms and/or comorbidities that would pose additional
             risk to them nor jeopardize the adequacy of study assessments.")

          7. History of a condition that compromises the immune system - human immunodeficiency
             virus infection, primary immunodeficiency, anatomic or functional asplenia; receipt of
             a hematopoietic stem cell or solid organ transplant at any time; receipt of
             immunosuppressive therapy including chemotherapeutic agents, biologic agents,
             antimetabolites or radiation therapy during the past 12 months; or daily use of
             systemic corticosteroids for more than 7 consecutive days during the past 14 days.

          8. Any other condition that in the judgment of the investigator precludes participation
             because it could affect the safety of the subject