Steroids Helping Albuterol Responders Exclusively

Study Overview
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Brief Summary
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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.

Official Title
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Are Steroids Efficacious in Hospitalized Patients With Bronchiolitis Who Show an Objective Clinical Improvement After Albuterol (Albuterol Responders)?

Conditions
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Bronchiolitis

Intervention / Treatment
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* Drug: prednisolone or methylprednisolone
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Weeks
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Responders/Placebo<br>Albuterol responders being given placebo | Drug: placebo<br>* oral or IV placebo<br>|
| Active Comparator: Responders/Steroids<br>albuterol responders being given steroids | Drug: prednisolone or methylprednisolone<br>* 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<br>* Other names: Orapred;|
| Placebo Comparator: Non-responders/placebo<br>non-albuterol responders being given placebo | Drug: placebo<br>* oral or IV placebo<br>|
| Active Comparator: non-responders/steroids<br>non-albuterol responders being given steroids | Drug: prednisolone or methylprednisolone<br>* 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<br>* Other names: Orapred;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| number of doses of bronchodilators used during hospitalization |  | variable, likely no more 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bronchiolitis, steroids, corticosteroids, albuterol, child, infant, pediatric