Status:
COMPLETED
Inhaled Corticosteroid Use to Prevent Acute Chest Syndrome Recurrence in Children Between 1 and 4 With Sickle Cell Disease: a Feasibility Trial
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
Emory University
Children's National Research Institute
Conditions:
Sickle Cell Disease
Asthma
Eligibility:
All Genders
1-4 years
Phase:
PHASE1
Brief Summary
Acute and chronic pulmonary complications with concomitant inflammatory response are a leading cause of morbidity and mortality in children with sickle cell disease (SCD). Acute chest syndrome (ACS), ...
Eligibility Criteria
Inclusion
- 1\) confirmed diagnosis of sickle cell disease (SCD)
- 2\) age between 1 and 4 years (must have reached 1st but not yet 4th birthday)
- 3\) a prior diagnosis of ACS, defined as acute respiratory illness with a new radiodensity on CXR, and one of the following: fever (temperature \> 38.50C), decrease in oxygen saturation more than 3% from baseline, or increase in respiratory rate above baseline
Exclusion
- 1\) patients already taking inhaled corticosteroids
- 2\) those receiving blood transfusions for elevated TCD or strokes
- 3\) presents over 2 weeks after discharge from hospital following initial ACS episode.
- Participants may be on hydroxyurea and participate in this trial.
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2017
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT02187445
Start Date
June 1 2014
End Date
February 13 2017
Last Update
February 17 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-9000