Steroid Use in Non-RSV Bronchiolitis

NCT04221087 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: STUDY19080287
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiolitis, Viral

Keywords

bronchiolitis; non-RSV bronchiolitis; dexamethasone; treatment; steroid

Outcome Measures

Primary Outcomes (1)

• Hospital Length of Stay

  Measurement of hospital length of stay in hours

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

Secondary Outcomes (4)

• Severity of Bronchiolitis

  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

• Severity of Bronchiolitis

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

• Severity of Bronchiolitis

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

• 7-day Same-Cause Revisit Rate

  Discharge to 7 days

Study Arms (2)

Placebo Arm

PLACEBO COMPARATOR

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.)

Drug: Placebos

Dexamethasone Arm

EXPERIMENTAL

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.)

Drug: Dexamethasone Oral

Interventions

Placebos DRUG

Sugar water based on same ml dosing of intervention arm drug

Also known as: sugar water

Placebo Arm

Dexamethasone Oral DRUG

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

Also known as: Decadron

Dexamethasone Arm

Eligibility Criteria

• Age: 1 Day - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Allison Williams: lead
• University of Pittsburgh Medical Center: collaborator

Study Sites (1)

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Bronchiolitis, Viral; Bronchiolitis

Interventions

Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Virus Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Dr. Allison Williams
• Organization: University of PIttsburgh

williamsae2@upmc.edu

4126925135

Study Officials

• Allison E Williams, MD

  University of Pittsbrgh, UPMC Children's Hospital of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

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

Study Record Dates

• First Submitted: December 29, 2019
• First Posted: January 9, 2020
• Study Start: February 3, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 21, 2023
• Results First Posted: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)