Steroids Helping Albuterol Responders Exclusively
Not Applicable
Withdrawn
- Conditions
- Bronchiolitis
- Interventions
- Drug: placebo
- Registration Number
- NCT00798616
- Lead Sponsor
- University Hospitals Cleveland Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Responders/Placebo placebo Albuterol responders being given placebo Responders/Steroids prednisolone or methylprednisolone albuterol responders being given steroids non-responders/steroids prednisolone or methylprednisolone non-albuterol responders being given steroids Non-responders/placebo placebo non-albuterol responders being given placebo
- Primary Outcome Measures
Name Time Method respiratory rate and respiratory distress score 4 hours length of hospitalization (actual and until meets "ready for discharge" criteria) variable, likely no more than 2 weeks
- Secondary Outcome Measures
Name Time Method need for increased respiratory support (intubation, CPAP, BiPAP) variable, likely up to 2 weeks amount of oxygen used during hospitalization variable, likely less than 2 weeks total duration of symptoms variable, likely no more than 3 weeks need for unanticipated medical care after discharge variable, likely no more than 3 weeks tachycardia and/or hypertension during hospitalization variable, likely no more than 2 weeks number of doses of bronchodilators used during hospitalization variable, likely no more than 2 weeks
Trial Locations
- Locations (1)
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States