Nasal Irrigation in Infants With Bronchiolitis.

Phase 3

Completed

• Conditions: Bronchiolitis
• Interventions: Drug: Isotonic solution (NaCl 0.9%); Drug: Hypertonic solution (NaCl 3%)

• Registration Number: NCT02162745
• Lead Sponsor: IRCCS Burlo Garofolo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-06
• Study First Submitted: 2014-06-11
• Study First Submitted QC: 2014-06-12
• Last Update Submitted: 2014-06-12
• Study First Posted: 2014-06-13
• Last Update Posted: 2014-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

Inclusion Criteria

• infants <1 year
• diagnosis of bronchiolitis with respiratory distress, rhinitis, cough
• oxygen saturation between 88 and 94%

Exclusion Criteria

• previous treatments (nasal irrigation or suctioning, oxygen, nebulized drugs, nebulized hypertonic solution, antipyretics up to 6 hours before the study entry, oral steroids at any time before study entry)
• chronic illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isotonic solution (NaCl 0.9%)	Isotonic solution (NaCl 0.9%)	Single nasal irrigation with 1 ml of isotonic solution (NaCl 0.9%) per each nostril
Hypertonic solution (NaCl 3%)	Hypertonic solution (NaCl 3%)	Single nasal irrigation with 1 ml of hypertonic solution (NaCl 3%) per each nostril

Primary Outcome Measures

Name	Time	Method
Oxygen saturation (%)	up to 50 minutes after allocation	Measurement of arterial oxygen saturation (SpO2) of hemoglobin with digital pulse oximeter

Secondary Outcome Measures

Name	Time	Method
Respiratory effort (WARME score)	5, 15, 20, 50 minutes after allocation	Evaluation of the respiratory effort using the validated WARME score (evaluation of: 1) respiratory rate; 2) prolonged expiration; 2) wheezing; 3) air exchange; 4) muscle use).

Trial Locations

Locations (2)

Pediatria, Azienda Ospedaliera Santa Maria Degli Angeli; 🇮🇹 Pordenone, Friuli Venezia Giulia, Italy

Emergency Department, IRCCS Burlo Garofolo; 🇮🇹 Trieste, Friuli Venezia Giulia, Italy