Pilot Study of Magnesium Infusions in Pediatric Asthma
This is a prospective randomized pilot study that seeks to address the research question: In children with moderate-to-severe asthma, do intravenous magnesium infusions added to standard Pediatric intensive care unit (PICU)-level asthma care significantly decrease time from patient presentation until PICU discharge?
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Magnesium Infusions (Drips) for Moderate-to-Severe Pediatric Asthma Exacerbations|
- Time to discharge [ Time Frame: Duration of hospital stay, typically 3-5 days ] [ Designated as safety issue: No ]The primary outcome for this study is elapsed time from emergency department (ED) presentation to readiness for PICU discharge.
- Beta receptor haplotype [ Time Frame: Once on enrollment ] [ Designated as safety issue: No ]The subject's genetic haplotype for beta adrenergic receptor. It will be determined by blood test during their admission in the hospital and enrollment on the study protocol.
|Study Start Date:||January 2012|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Magnesium
Half the enrolled subjects will be randomized to receive active drug, a magnesium infusion.
Drug: Magnesium Sulfate
Continuous magnesium drip, titrated to effect until patient's symptoms improve
Placebo Comparator: Control
Half the subjects will be randomized to receive a drip that does not have active drug (magnesium sulfate).
Simple saline drip, without active drug
This study will be a double-blind, prospective randomized pilot study. Subjects will be randomized on a 1:1 basis to receive routine asthma care with or without a magnesium drip.
|Contact: Keith Cross, MDfirstname.lastname@example.org|
|Contact: Kendra Sikes||502-629-7212|
|United States, Kentucky|
|Kosair Children's Hospital||Recruiting|
|Louisville, Kentucky, United States, 40204|
|Contact: Keith 502-689-2457 email@example.com|
|Principal Investigator: Keith Cross, MD|