A randomized, multicenter, controlled trial of the effectiveness of nebulized therapy with 3% hypertonic saline solution compared with 0.9% saline solution in hospitalized infants with RS viral bronchiolitis.
Phase 3
- Conditions
- RS viral bronchiolitis
- Registration Number
- JPRN-UMIN000001700
- Lead Sponsor
- Tokyo Metropolitan Children's medical center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
Not provided
Exclusion Criteria
1)pCO2 is more than 60 mm Hg by venous blood gas or SpO2 is under 95 % under administration of oxygen. 2)diagnosed episode of wheezing previously. 3)Cerebral palsy, congenital heart desease, lung disease, muscular disorder, malformed syndrome, immune deficiency disorder 4)a patient who was born by premature birth equal to or less than several a week 35 weeks for gestational ages 5)a patients administrated palivizumab. 6)a patients with apnea 7)Judged a patients needed intubation by the physicians. 8)Judged inappropriate for this study by the physicians.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method length of hospital stay; time to satisfy discharge criteria
- Secondary Outcome Measures
Name Time Method Actual length of hospital stay Change of clinical severity score of hospitalization and 72hr plus and minus 12hr after hospitalization Duration of O2 administration Number of additional inhalation Rate of ventilator use