Clinical trial NCT00798616: Steroids Helping Albuterol Responders Exclusively
Official title: Are Steroids Efficacious in Hospitalized Patients With Bronchiolitis Who Show an Objective Clinical Improvement After Albuterol ("Albuterol Responders")?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Bronchiolitis
Keywords: bronchiolitis
steroids
corticosteroids
albuterol
child
infant
pediatric
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2008-11-26
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: respiratory rate and respiratory distress score
timeFrame: 4 hours
measure: length of hospitalization (actual and until meets "ready for discharge" criteria)
timeFrame: variable, likely no more than 2 weeks
Secondary outcomes:
measure: need for increased respiratory support (intubation, CPAP, BiPAP)
timeFrame: variable, likely up to 2 weeks
measure: amount of oxygen used during hospitalization
timeFrame: variable, likely less than 2 weeks
measure: number of doses of bronchodilators used during hospitalization
timeFrame: variable, likely no more than 2 weeks
measure: total duration of symptoms
timeFrame: variable, likely no more than 3 weeks
measure: need for unanticipated medical care after discharge
timeFrame: variable, likely no more than 3 weeks
measure: tachycardia and/or hypertension during hospitalization
timeFrame: variable, likely no more than 2 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Steven L Shein, MD
role: PRINCIPAL_INVESTIGATOR
References:
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