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Steroids Helping Albuterol Responders Exclusively (SHARE)

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ClinicalTrials.gov Identifier: NCT00798616
Recruitment Status : Withdrawn (We were unable to enroll a sufficient number of patients due to manpower.)
First Posted : November 26, 2008
Last Update Posted : December 9, 2014
Sponsor:
Information provided by:
University Hospitals Cleveland Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bronchiolitis Drug: prednisolone or methylprednisolone Drug: placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Are Steroids Efficacious in Hospitalized Patients With Bronchiolitis Who Show an Objective Clinical Improvement After Albuterol ("Albuterol Responders")?

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Responders/Placebo
Albuterol responders being given placebo
 Drug: placebo
oral or IV placebo
Active Comparator: Responders/Steroids
albuterol responders being given steroids
 Drug: prednisolone or methylprednisolone
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
Other Names:
  • corticosteroids
  • Solu-Medrol
  • Orapred
Placebo Comparator: Non-responders/placebo
non-albuterol responders being given placebo
 Drug: placebo
oral or IV placebo
Active Comparator: non-responders/steroids
non-albuterol responders being given steroids
 Drug: prednisolone or methylprednisolone
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
Other Names:
  • corticosteroids
  • Solu-Medrol
  • Orapred


Outcome Measures
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Primary Outcome Measures :
  1. respiratory rate and respiratory distress score [ Time Frame: 4 hours ]
  2. length of hospitalization (actual and until meets "ready for discharge" criteria) [ Time Frame: variable, likely no more than 2 weeks ]

Secondary Outcome Measures :
  1. need for increased respiratory support (intubation, CPAP, BiPAP) [ Time Frame: variable, likely up to 2 weeks ]
  2. amount of oxygen used during hospitalization [ Time Frame: variable, likely less than 2 weeks ]
  3. number of doses of bronchodilators used during hospitalization [ Time Frame: variable, likely no more than 2 weeks ]
  4. total duration of symptoms [ Time Frame: variable, likely no more than 3 weeks ]
  5. need for unanticipated medical care after discharge [ Time Frame: variable, likely no more than 3 weeks ]
  6. tachycardia and/or hypertension during hospitalization [ Time Frame: variable, likely no more than 2 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   4 Weeks to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00798616


Locations
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United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Investigators
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Principal Investigator: Steven L Shein, MD University Hospitals Cleveland Medical Center
More Information
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Publications:

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Responsible Party: Steven Shein, Chief Resident, Department of Pediatrics, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT00798616    
Other Study ID Numbers: UHC 07-08-36
First Posted: November 26, 2008    Key Record Dates
Last Update Posted: December 9, 2014
Last Verified: October 2010
Keywords provided by University Hospitals Cleveland Medical Center:
bronchiolitis
steroids
corticosteroids
albuterol
 child
infant
pediatric
Additional relevant MeSH terms:
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Bronchiolitis
Bronchitis
Respiratory Tract Infections
Infections
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
 Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents