NCT02538458

Efficacy and Safety of 3% Hypertonic Saline Inhalation (24h vs 72h) to Treat Acute Bronchiolitis in Hospitalized Infants

Effects of Reduction of the Length of Treatment by Nebulized 3% Hypertonic Saline From 72 to 24 Hours on Clinical Remission, in Children Younger Than 12 Month Hospitalized for Acute Bronchiolitis. BRONDUSAL

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 1 Minute – 12 Months
• Healthy volunteers: Not accepted

Summary

Efficacy/Safety of 3% hypertonic saline inhalation (24H vs 72H) to treat acute bronchiolitis in infants.

Detailed description

In acute bronchiolitis in infants, 3% hypertonic saline nebulizations proved to be efficient, reducing the hospitalization length and clinical severity scores. Among the questions remaining, treatment length is still being discussed in the literature. The trial hypothesis is that the efficiency of a 24 hours treatment by 3% hypertonic saline is not inferior to a 72 hours treatment, in acute bronchiolitis in infants. The primary objective of the study is to compare the efficiency of a 24 hours treatment by 3 % hypertonic saline, versus a 72 hours treatment maximum, on clinical remission, judged by the Wang score measured 72 hours after starting treatment, in children younger than 12 month hospitalized for acute bronchiolitis.

Conditions

• Bronchiolitis

Interventions

Type	Name	Description
DRUG	3 % hypertonic saline up to 72H	Treatment by inhalation of 3 % hypertonic saline, up to 72H. Test group.
DRUG	3 % hypertonic saline up to 24H	* Treatment by inhalation of 3 % hypertonic saline, up to 24H. * followed by 48h of placebo : isotonic saline inhalation. Placebo control group.

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2015-09-02
• Last updated: 2017-11-06

Locations

1 site across 1 country: France