Dexamethasone Use for the Treatment of Non-RSV Bronchiolitis

STUDY19080287

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.

2020-02-03

2022-12-31

2022-12-31

Terminated

Early phase I

3

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized to either intervention or control group upon admission if they meet inclusion/exclusion criteria and consent.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 3, 'type': 'ACTUAL'}}

2023-03-21