NCT02162745

Nasal Irrigation in Infants With Bronchiolitis.

Randomized Controlled Trial to Evaluate the Efficacy of Nasal Irrigation in Infants With Bronchiolitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: IRCCS Burlo Garofolo · Academic / Other
• Sex: All
• Age: 1 Day – 365 Days
• Healthy volunteers: Not accepted

Summary

Bronchiolitis is a leading cause of acute illness and hospitalization in the first year of life. Most children with bronchiolitis have mild disease and are managed at home with support from primary care providers, while children with more severe symptoms require supportive therapy with oxygen and fluid administration. Neonates may be obligate nasal breathers until they are at least 2 months old and nasal obstruction may play a relevant role in respiratory resistances throughout the first months of life, whereas nasal passages may exhibit as much as 50% of the total airway resistance. Some guidelines recommend to clear the nostrils of secretions to improve airway patency but no controlled trial on the efficacy of nasal irrigation in infants with bronchiolitis was carried out. The aim of this randomized controlled trial is to compare normal saline and hypertonic solution for nasal irrigation versus simple supportive care in infants admitted to Emergency Department with bronchiolitis and mild desaturation.

Conditions

• Bronchiolitis

Interventions

Type	Name	Description
DRUG	Isotonic solution (NaCl 0.9%)
DRUG	Hypertonic solution (NaCl 3%)

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2014-06-13
• Last updated: 2014-06-13

Locations

2 sites across 1 country: Italy