Steroid Use in Non-RSV Bronchiolitis

NCT ID: NCT04221087

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-03
• Study Completion Date: 2022-12-31

Brief 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.

Detailed Description

The study will take place at UPMC Children's Hospital of Pittsburgh with patients admitted to the general pediatric service. The attending physician on the clinical service team will identify patients diagnosed with bronchiolitis. If the participant meets inclusion and exclusion criteria, a member from the study team will then meet with the participant's family to discuss the study and obtained informed consent. A participant may have had a rapid RSV/influenza testing already complete for clinical purposes. If this has been done, participants will be asked to obtain a secondary nasopharyngeal swab so that it may be tested for a full respiratory viral panel for statistical stratification. Once rapid testing is obtained and results are negative for both RSV and influenza, the participant will then be randomized to either the intervention (dexamethasone) or control (placebo) arm of the study. Study members will calculate a modified Tal score (MTS) at time of consent and then 12-24 hours after medication administration. Throughout admission, participants will also receive standard of care for bronchiolitis, which may include regular vital sign evaluation, supplemental oxygen, intravenous fluids or nasogastric tube feedings, and anti-pyretic therapy. Because this is a pilot study, the study will be underpowered, however, this study will provide data that will allow the investigators to estimate the sample size needed for a future study. The number of time points to be used for the generalized estimating equation can be determined ad hoc to include a reasonably balanced sample to make the comparison valid.

Conditions

Bronchiolitis, Viral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo Arm

Participants will be given a placebo of sugar water (0.6ml/kg/dose) in a single oral dose and standard of care for bronchiolitis (supplemental oxygen, antipyretics, suctioning etc.)

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

Sugar water based on same ml dosing of intervention arm drug

Dexamethasone Arm

Participants will be given dexamethasone (0.6mg/kg/dose) in a single oral dose in addition to the standard of care for bronchiolitis (supplemental oxygen, antipyretics, suctioning etc.)

Group Type: EXPERIMENTAL

Dexamethasone Oral

Intervention Type: DRUG

0.6mg/kg/dose - single oral dose administration to intervention arm

Interventions

Placebos

Sugar water based on same ml dosing of intervention arm drug

Intervention Type: DRUG

Dexamethasone Oral

0.6mg/kg/dose - single oral dose administration to intervention arm

Intervention Type: DRUG

Other Intervention Names

sugar water; Decadron

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh Medical Center

OTHER

Sponsor Role: collaborator

Allison Williams

OTHER

Sponsor Role: lead

Responsible Party

Allison Williams

Assistant Professor of Pediatrics

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Allison E Williams, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsbrgh, UPMC Children's Hospital of Pittsburgh

Locations

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY19080287

Identifier Type: -

Identifier Source: org_study_id