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Steroids Helping Albuterol Responders Exclusively (SHARE)

Primary Purpose

Bronchiolitis

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
prednisolone or methylprednisolone
placebo
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis focused on measuring bronchiolitis, steroids, corticosteroids, albuterol, child, infant, pediatric

Eligibility Criteria

4 Weeks - 24 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of bronchiolitis
  • Respiratory Distress Assessment Index score of 4 or more

Exclusion Criteria:

  • prior prescription of bronchodilators or inhaled corticosteroids
  • birth at <36 weeks gestation
  • chronic cardiac disease
  • chronic pulmonary disease (including asthma)
  • immunodeficiency
  • non-topical steroid use in the prior week
  • parents that don't understand English
  • baseline systolic blood pressure >118 mmHg
  • home oxygen use
  • evidence of systemic fungal or varicella infection
  • bronchodilator use in the prior week
  • allergy to albuterol or corticosteroids

Sites / Locations

  • University Hospitals of Cleveland

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Responders/Placebo

Responders/Steroids

Non-responders/placebo

non-responders/steroids

Arm Description

Albuterol responders being given placebo

albuterol responders being given steroids

non-albuterol responders being given placebo

non-albuterol responders being given steroids

Outcomes

Primary Outcome Measures

respiratory rate and respiratory distress score
length of hospitalization (actual and until meets "ready for discharge" criteria)

Secondary Outcome Measures

need for increased respiratory support (intubation, CPAP, BiPAP)
amount of oxygen used during hospitalization
number of doses of bronchodilators used during hospitalization
total duration of symptoms
need for unanticipated medical care after discharge
tachycardia and/or hypertension during hospitalization

Full Information

First Posted
November 25, 2008
Last Updated
December 5, 2014
Sponsor
University Hospitals Cleveland Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00798616
Brief Title
Steroids Helping Albuterol Responders Exclusively
Acronym
SHARE
Official Title
Are Steroids Efficacious in Hospitalized Patients With Bronchiolitis Who Show an Objective Clinical Improvement After Albuterol ("Albuterol Responders")?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Withdrawn
Why Stopped
We were unable to enroll a sufficient number of patients due to manpower.
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospitals Cleveland Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to determine whether corticosteroids are beneficial to children with bronchiolitis whose breathing gets better after being given a breathing treatment with albuterol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
bronchiolitis, steroids, corticosteroids, albuterol, child, infant, pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Responders/Placebo
Arm Type
Placebo Comparator
Arm Description
Albuterol responders being given placebo
Arm Title
Responders/Steroids
Arm Type
Active Comparator
Arm Description
albuterol responders being given steroids
Arm Title
Non-responders/placebo
Arm Type
Placebo Comparator
Arm Description
non-albuterol responders being given placebo
Arm Title
non-responders/steroids
Arm Type
Active Comparator
Arm Description
non-albuterol responders being given steroids
Intervention Type
Drug
Intervention Name(s)
prednisolone or methylprednisolone
Other Intervention Name(s)
corticosteroids, Solu-Medrol, Orapred
Intervention Description
either prednisolone 2mg/kg PO once daily or methylprednisolone 1.6mg/kg IV once daily (if IV access is present) for length of hospitalization, for a maximum of seven days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
oral or IV placebo
Primary Outcome Measure Information:
Title
respiratory rate and respiratory distress score
Time Frame
4 hours
Title
length of hospitalization (actual and until meets "ready for discharge" criteria)
Time Frame
variable, likely no more than 2 weeks
Secondary Outcome Measure Information:
Title
need for increased respiratory support (intubation, CPAP, BiPAP)
Time Frame
variable, likely up to 2 weeks
Title
amount of oxygen used during hospitalization
Time Frame
variable, likely less than 2 weeks
Title
number of doses of bronchodilators used during hospitalization
Time Frame
variable, likely no more than 2 weeks
Title
total duration of symptoms
Time Frame
variable, likely no more than 3 weeks
Title
need for unanticipated medical care after discharge
Time Frame
variable, likely no more than 3 weeks
Title
tachycardia and/or hypertension during hospitalization
Time Frame
variable, likely no more than 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Weeks
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of bronchiolitis Respiratory Distress Assessment Index score of 4 or more Exclusion Criteria: prior prescription of bronchodilators or inhaled corticosteroids birth at <36 weeks gestation chronic cardiac disease chronic pulmonary disease (including asthma) immunodeficiency non-topical steroid use in the prior week parents that don't understand English baseline systolic blood pressure >118 mmHg home oxygen use evidence of systemic fungal or varicella infection bronchodilator use in the prior week allergy to albuterol or corticosteroids
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven L Shein, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Citations:
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17015575
Citation
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Steroids Helping Albuterol Responders Exclusively

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