Steroids in Children Hospitalized With Asthma
Steroids in Children Hospitalized With Asthma
Asthma is the most common chronic disease of children. A short (3-5 day) course of a
 short-acting steroid such as Prednisone or Prednisolone has long been the standard of care
 for asthma exacerbation. Dexamethasone efficacy in asthma exacerbation has been studied in
 the outpatient setting and was found to be as effective as Prednisone. Dexamethasone has the
 advantage of shorter course, more compliance, and more tolerable. This has led many emergency
 departments to provide a 1-2 dose course of Dexamethasone on discharge. Thus, many inpatients
 have received a first dose of Dexamethasone prior to reaching the inpatient unit, leading to
 confusion about the best plan for these patients. Many hospitalist pediatricians continue to
 give a 5-day total course with Prednisone, but some patients have begun to receive a second
 dose of Dexamethasone 24 hours after the first dose. To our knowledge, no studies have been
 done to compare the efficacy of these two protocols in pediatric patients requiring
 hospitalization. The hypothesis is that a second dose of Dexamethasone is as effective as
 four additional days of Prednisone in hospitalized children with asthma exacerbation. This is
 an open label, randomized control study comparing these treatments in children age 2-18
 hospitalized with asthma exacerbation who have received a first dose of Dexamethasone.
Corticosteroids are the first-line therapy for managing acute asthma exacerbations. Studies
 have shown that systemic steroids effect decrease relapse and hospital admission. Due to its
 short half-life, Prednisone is usually given daily or twice daily for 3-5 days. It has been
 associated with poor compliance due it the prolonged course. Dexamethasone half-life is 36 -
 72 hours.

 Several studies have shown no difference in outcomes between 3-5 days of prednisone and
 different forms of dexamethasone, including single intramuscular dose or single oral dose or
 two oral doses 1 day apart. However, those studies were done in the emergency department
 (ED). Lack of response to initial asthma treatment in ED results in admission to the
 hospital, implying more severe exacerbation than those able to be discharged. Some clinician
 shift to oral prednisone once admitted to the floor for patients who have received
 Dexamethasone or not. Others have begin to complete the Dexamethasone course with one more
 dose of Dexamethasone 24 hour after the first dose. Dexamethasone has the advantage of
 compliance and tolerability, however, no studies investigated its efficacy in hospitalized
 patients. Such knowledge will improve patient's compliance and outcomes.

 -  Sample size calculation: Primary outcome of return to normal activities within 3 days of
 discharge. Based on previous studies, it is estimated that 70% of the control group will
 achieve this goal. Based on a minimum absolute difference of 15%, and a power of 0.80,
 the sample size calculated to be 117 in each arm. Assuming 20% lost to follow up, it is
 intended to recruit 150 in each arm (total 300 subjects).

 -  Statistical Analysis: Demographics will be analyzed to ensure the experimental and
 control groups are equivalent at baseline. All proportions will be tested with
 Chi-square or Fisher exact test and two-sample T-test will be used for continuous
 variables. α = 0.05 will be used for all hypothesis tests. Interim analysis will be
 performed monthly and the study will be halted if any safety concerns arise. The Center
 for Health Equity and Quality Research (CHEQR) will help with statistical analysis

 -  Data Safety and Monitoring Plan: The study PI and co-investigator will meet and review
 the collected data on a monthly basis and identify any interim results that may require
 a change of study protocol. Information that may affect subjects' safety will be
 communicated to appropriate parties in a timely fashion.
Inclusion Criteria:

 -  Signed informed consent by legal guardian

 -  Age 2 to 18 years old

 -  Admission to the floor with acute asthma exacerbation.

 -  Received single dose of oral Dexamethasone

 -  Initial Pediatric Asthma Score (PAS) of 8 or higher.

 Exclusion Criteria:

 -  Admission to PICU

 -  Recent steroid use (within 1 month)

 -  Cardiac disorder, chronic respiratory illness (BPD or CF)

 -  Stridor

 -  Bacterial Pneumonia