Steroids Helping Albuterol Responders Exclusively

University Hospitals Cleveland Medical Center

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Bronchiolitis

Interventions

prednisolone or methylprednisoloneDRUG

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

placeboDRUG

oral or IV placebo

Eligibility

Sex: ALLMin age: 4 WeeksMax age: 24 Months

Medical Language ↔ Plain English

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

Locations (1)

University Hospitals of Cleveland

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

respiratory rate and respiratory distress score

Time frame: 4 hours

length of hospitalization (actual and until meets "ready for discharge" criteria)

Time frame: variable, likely no more than 2 weeks

Secondary Outcomes

need for increased respiratory support (intubation, CPAP, BiPAP)

Time frame: variable, likely up to 2 weeks

amount of oxygen used during hospitalization

Time frame: variable, likely less than 2 weeks

number of doses of bronchodilators used during hospitalization

Time frame: variable, likely no more than 2 weeks

total duration of symptoms

Time frame: variable, likely no more than 3 weeks

need for unanticipated medical care after discharge

Time frame: variable, likely no more than 3 weeks

tachycardia and/or hypertension during hospitalization

Time frame: variable, likely no more than 2 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.