Status:
COMPLETED
Hypertonic Saline for Acute Bronchiolitis
Lead Sponsor:
Children's Hospital of Philadelphia
Conditions:
Bronchiolitis, Viral
Saline Solution, Hypertonic
Eligibility:
All Genders
2-23 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether nebulized 3% hypertonic saline (HS) improves respiratory distress in children 2-23 months presenting to the emergency department (ED) with acute bronc...
Detailed Description
Acute bronchiolitis is the most frequent cause of infant hospitalization in the United States. Bronchiolitis typically refers to a viral lower respiratory tract infection during the first two years of...
Eligibility Criteria
Inclusion
- Age 8 weeks through 23 months
- First episode of wheezing associated with respiratory distress and upper respiratory tract infection.
- Respiratory Distress Assessment Instrument (RDAI) rating of ≥4 and ≤15 after initial albuterol nebulization per standard care
- Pediatric Emergency Medicine (PEM) physician does not plan additional bronchodilator therapy within the hour after initial assessment.
- Parental/guardian permission (informed consent)
Exclusion
- Subjects with prior history of wheezing or asthma or who have received bronchodilator therapy prior to the current illness
- Chronic lung or heart disease
- Critically ill infants requiring immediate airway stabilization
- Non-English speaking parent/guardian
- Inability to take nebulized medications
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01247064
Start Date
October 1 2010
End Date
December 1 2011
Last Update
August 19 2014
Active Locations (1)
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1
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104