Pilot Study of Magnesium Infusions in Pediatric Asthma
Withdrawn before enrolling · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Asthma
In brief
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?
Key facts
- Study ID
- NCT01522040
- Run by
- University of Louisville
- People needed
- 0
- Starts
- 2012-01-01
- Expected to finish
- 2013-10-01
- Last updated by the study team
- 2017-03-30
Who can join
Age: 2 and older, up to 20. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 2 years 0 days up to 20 years 364 days
- Clinical diagnosis of asthma including both of the following:
- Attending physician's primary working diagnosis is status asthmaticus
- Results of a modified International Study of Asthma and Allergies in Children (ISAAC) diagnostic questionnaire consistent with an asthma diagnosis
- Planned PICU admission for moderate-to-severe asthma exacerbation persisting despite standard first-tier therapy (systemic corticosteroids and at least a one-hour treatment with nebulized albuterol/ipratroprium or equivalent) as evidenced by an asthma score of 7 or greater
- IV access or equivalent
- Ability to understand and give informed consent/assent in English
You may not qualify if…
- Prior enrollment in this study
- Prior adverse reactions to magnesium
- Use of systemic corticosteroids or magnesium in preceding 2 weeks, or administered at a transferring facility more than 3 hours prior to enrollment
- Admission for inpatient asthma care in preceding 2 weeks
- Hemodynamic instability, impending respiratory failure or intubation
- Inability in children age 7 years or older to give assent due to a developmental delay or altered mental status
- Significant renal or cardiac disease
- Sickle cell anemia
- Significant, active non-asthma pulmonary disease
Where it is running
- Kosair Children's Hospital — Louisville, Kentucky, United States
Full record on ClinicalTrials.gov
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