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Sponsored by: |
University Hospitals of Cleveland |
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Information provided by: | University Hospitals of Cleveland |
ClinicalTrials.gov Identifier: | NCT00798616 |
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 | Intervention |
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Bronchiolitis |
Drug: prednisolone or methylprednisolone Drug: placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Are Steroids Efficacious in Hospitalized Patients With Bronchiolitis Who Show an Objective Clinical Improvement After Albuterol ("Albuterol Responders")? |
Estimated Enrollment: | 100 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Responders/Placebo: Placebo Comparator
Albuterol responders being given placebo
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Drug: placebo
oral or IV placebo
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Responders/Steroids: Active Comparator
albuterol responders being given steroids
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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
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Non-responders/placebo: Placebo Comparator
non-albuterol responders being given placebo
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Drug: placebo
oral or IV placebo
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non-responders/steroids: Active Comparator
non-albuterol responders being given steroids
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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
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Ages Eligible for Study: | up to 24 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Steven L Shein, MD | 216-844-1117 | drstevenshein@gmail.com |
Contact: Ethan Leonard, MD | 216-844-8735 | ethan.leonard@uhhs.com |
United States, Ohio | |
University Hospitals of Cleveland | |
Cleveland, Ohio, United States, 44106 |
Principal Investigator: | Steven L Shein, MD | University Hospitals of Cleveland |
Responsible Party: | University Hospitals of Cleveland ( Steven Shein, Chief Resident, Department of Pediatrics ) |
Study ID Numbers: | UHC 07-08-36 |
Study First Received: | November 25, 2008 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00798616 History of Changes |
Health Authority: | United States: Institutional Review Board |
bronchiolitis steroids corticosteroids albuterol |
child infant pediatric |
Anti-Inflammatory Agents Neurotransmitter Agents Bronchial Diseases Adrenergic Agents Methylprednisolone Hormone Antagonists Albuterol Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Prednisolone acetate Neuroprotective Agents Hormones Adrenergic Agonists Lung Diseases, Obstructive |
Respiratory Tract Infections Respiratory Tract Diseases Bronchitis Methylprednisolone Hemisuccinate Antineoplastic Agents, Hormonal Adrenergic beta-Agonists Bronchiolitis Methylprednisolone acetate Anti-Asthmatic Agents Glucocorticoids Lung Diseases Prednisolone Peripheral Nervous System Agents Bronchodilator Agents |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Bronchial Diseases Antineoplastic Agents Methylprednisolone Albuterol Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Prednisolone acetate Reproductive Control Agents Neuroprotective Agents |
Hormones Adrenergic Agonists Lung Diseases, Obstructive Respiratory Tract Infections Respiratory Tract Diseases Tocolytic Agents Therapeutic Uses Bronchitis Methylprednisolone Hemisuccinate Antineoplastic Agents, Hormonal Adrenergic beta-Agonists Bronchiolitis Gastrointestinal Agents Methylprednisolone acetate Anti-Asthmatic Agents |