Status:
WITHDRAWN
Treating Wheezing in Children With Hypertonic Saline (TWICS)
Lead Sponsor:
Dr. Michael Flavin
Conditions:
Wheeze
Eligibility:
All Genders
2-6 years
Phase:
PHASE2
Brief Summary
Hypothesis: substitution of nebulized 3% NaCl (HS) for the standard normal saline (NS) used in bronchodilator therapy for acute viral wheezing in all children under age 6 years will provide superior s...
Detailed Description
the brief summary captures the essence of the study
Eligibility Criteria
Inclusion
- Age under 6 years
- History of viral upper respiratory infection within previous 7 days
- Wheezing or crackles detected on chest auscultation
- Respiratory Distress Assessment Instrument (RDAI) score of 4 or greater or oxygen saturation (SaO2) of 94% or less in room air.
Exclusion
- History of immunodeficiency, chronic cardiopulmonary disease (other than past history of wheezing), Down syndrome, gestational age under 34 weeks.
- Severe illness at presentation as defined by any of the following
- respiratory rate greater than 80/min
- SaO2 less than 88% in room air
- need for assisted ventilation
- Use of nebulized HS within previous 12 hours
- Presence of active varicella infection.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01868932
Start Date
October 1 2013
End Date
November 1 2013
Last Update
November 13 2015
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