Bronchiolitis
Conditions
Keywords
bronchiolitis, steroids, corticosteroids, albuterol, child, infant, pediatric
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.
Interventions
DRUGprednisolone 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
DRUGplacebo
oral or IV placebo
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Weeks to 24 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 increased respiratory support (intubation, CPAP, BiPAP) | variable, likely up to 2 weeks |
| tachycardia and/or hypertension during hospitalization | variable, likely no more than 2 weeks |
| need for unanticipated medical care after discharge | variable, likely no more than 3 weeks |
| amount of oxygen used during hospitalization | variable, likely less than 2 weeks |
Countries
United States
Outcome results
None listed