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.

UMIN ID: UMIN000001700

Registered date:10/02/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: RS viral bronchiolitis
• Date of first enrollment: 2008/11/01
• Target sample size: 120
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

nebulized 3% saline solution + beta stimulator
nebulized 0.9% saline solution + beta stimulator

Outcome(s)

• Primary Outcome: length of hospital stay; time to satisfy discharge criteria
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 12months-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Tokyo Metropolitan Children's medical center Hospital
• Secondary Sponsor: none
• Source(s) of Monetary Support: none