Clinical Trial: High Flow Therapy vs Hypertonic Saline in Bronchiolitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: High Flow Therapy vs Hypertonic Saline in Bronchiolitis Treatment. Randomized Controlled Trial

Brief Summary: The purpose of this study is to demonstrate that heated, humidified, high-flow nasal cannula (HHHFNC) is superior to hypertonic saline solution (HSS) in the treatment of moderate acute viral bronchiolitis in infants in improving respiratory distress and comfort and reducing length of hospital stay (LOS) and admission to Pediatric Intensive Care Unit (PICU).

Detailed Summary:
Sponsor: Ministry of Health, Spain

Current Primary Outcome: Difference in mean Respiratory Assessment Change Score (RACS) between groups in every time considered [ Time Frame: Every 4h for three consecutive times beginning in the moment of inclusion in the study and after every 8h for three consecutive times (average of 36h) ]

RACS is calculated by combining 2 values: the difference between the Respiratory Distress Assessment Instrument (RDAI) score before and after treatment, plus a value of +1 for each 10% improvement (decrease) in the posttreatment respiratory rate (RR) or a value of -1 for each 10% worsening (increase) in RR.


Original Primary Outcome: Same as current

Current Secondary Outcome: Difference in mean comfort score along the monitoring period between groups [ Time Frame: Every 8h for 6 consecutive times (two days) beginning in the moment of inclusion in the study ]

A scale was used for comfort evaluation . It is based on 4 items: rest, feeding, alertness and facial expression (facial pictures).Minimum 4-Maximum 16


Original Secondary Outcome: Same as current

Information By: Ministry of Health, Spain

Dates:
Date Received: May 29, 2013
Date Started: October 2010
Date Completion:
Last Updated: June 5, 2013
Last Verified: June 2013