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Steroid Use in Non-RSV Bronchiolitis

Primary Purpose

Bronchiolitis, Viral

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Placebos

Dexamethasone Oral

About this trial

This is an interventional treatment trial for Bronchiolitis, Viral focused on measuring bronchiolitis, non-RSV bronchiolitis, dexamethasone, treatment, steroid

Eligibility Criteria

1 Day - 2 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Less than or equal to 24 months
First episode of wheezing or first clinical diagnosis of bronchiolitis
Admitted to the general pediatric service at UPMC Children's Hospital of Pittsburgh
Ability of a parent or guardian to understand and comply with the study procedures
Signed written informed consent by parent or guardian

Exclusion Criteria:

Preterm birth < 35 weeks
Presence of underlying cardiopulmonary, neuromuscular, or other complex disease
Admission to the pediatric intensive care unit
Co-infection with influenza infection or concomitant bacterial infection (such as pneumonia or AOM)
History of allergy or reaction to steroids
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.")
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.
Any other condition that in the judgment of the investigator precludes participation because it could affect the safety of the subject

Sites / Locations

UPMC Children's Hospital of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Arm

Dexamethasone Arm

Arm Description

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.)

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.)

Outcomes

Primary Outcome Measures

Hospital Length of Stay

Measurement of hospital length of stay in hours

Secondary Outcome Measures

Severity of Bronchiolitis

Measurement of reducing severity of bronchiolitis by assessment with modified TAL score (MTS)

Severity of Bronchiolitis

Measurement of reducing severity of bronchiolitis by assessment with modified TAL score (MTS)

Severity of Bronchiolitis

Measurement of reducing severity of bronchiolitis by evaluation of patient outcome - discharge, transfer to ICU or acute care floor

7-day Same-Cause Revisit Rate

Measuring number of revisits to the primary care physician or emergency room or re-admission to the hospital for ongoing bronchiolitis related symptoms within 7 days of discharge

Full Information

NCT ID

NCT04221087

First Posted

December 29, 2019

Last Updated

March 15, 2023

Sponsor

Allison Williams

Collaborators

University of Pittsburgh Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04221087

Brief Title

Steroid Use in Non-RSV Bronchiolitis

Official Title

Dexamethasone Use for the Treatment of Non-RSV Bronchiolitis

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Terminated

Why Stopped

COVID19-pandemic, RSV surge

Study Start Date

February 3, 2020 (Actual)

Primary Completion Date

December 31, 2022 (Actual)

Study Completion Date

December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Allison Williams

Collaborators

University of Pittsburgh Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bronchiolitis, Viral

Keywords

bronchiolitis, non-RSV bronchiolitis, dexamethasone, treatment, steroid

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Participants will be randomized to either intervention or control group upon admission if they meet inclusion/exclusion criteria and consent.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo Arm

Arm Type

Placebo Comparator

Arm Description

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.)

Arm Title

Dexamethasone Arm

Arm Type

Experimental

Arm Description

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.)

Intervention Type

Drug

Intervention Name(s)

Placebos

Other Intervention Name(s)

sugar water

Intervention Description

Sugar water based on same ml dosing of intervention arm drug

Intervention Type

Drug

Intervention Name(s)

Dexamethasone Oral

Other Intervention Name(s)

Decadron

Intervention Description

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

Primary Outcome Measure Information:

Title

Hospital Length of Stay

Description

Measurement of hospital length of stay in hours

Time Frame

Admission vitals through discharge paperwork printing time, average of 24-96 hours

Secondary Outcome Measure Information:

Title

Severity of Bronchiolitis

Description

Measurement of reducing severity of bronchiolitis by assessment with modified TAL score (MTS)

Time Frame

Will obtain MTS upon admission by chart view or, if unable, at time of enrollment, and compare to MTS obtained 12 hours after medication administration

Title

Severity of Bronchiolitis

Description

Measurement of reducing severity of bronchiolitis by assessment with modified TAL score (MTS)

Time Frame

Will compare respiratory assessment via MTS 12 hours after admission and at discharge, average of 24-96 hours from admission

Title

Severity of Bronchiolitis

Description

Measurement of reducing severity of bronchiolitis by evaluation of patient outcome - discharge, transfer to ICU or acute care floor

Time Frame

Admission to time of discharge to home or transfer to ICU or acute care floor, usual time frame is 24-72 hours

Title

7-day Same-Cause Revisit Rate

Description

Measuring number of revisits to the primary care physician or emergency room or re-admission to the hospital for ongoing bronchiolitis related symptoms within 7 days of discharge

Time Frame

Discharge to 7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Maximum Age & Unit of Time

2 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Less than or equal to 24 months First episode of wheezing or first clinical diagnosis of bronchiolitis Admitted to the general pediatric service at UPMC Children's Hospital of Pittsburgh Ability of a parent or guardian to understand and comply with the study procedures Signed written informed consent by parent or guardian Exclusion Criteria: Preterm birth < 35 weeks Presence of underlying cardiopulmonary, neuromuscular, or other complex disease Admission to the pediatric intensive care unit Co-infection with influenza infection or concomitant bacterial infection (such as pneumonia or AOM) History of allergy or reaction to steroids 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.") 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. Any other condition that in the judgment of the investigator precludes participation because it could affect the safety of the subject

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Allison E Williams, MD

Organizational Affiliation

University of Pittsbrgh, UPMC Children's Hospital of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

UPMC Children's Hospital of Pittsburgh

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15224

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Steroid Use in Non-RSV Bronchiolitis

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