Nasal Irrigation in Infants With Bronchiolitis.

Bronchiolitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02162745
• Other study ID #: RC 35/12
• Status: Completed
• Phase: Phase 3
• First received: June 11, 2014
• Last updated: June 12, 2014
• Start date: October 2012
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: IRCCS Burlo Garofolo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 365 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

Drug:
• Isotonic solution (NaCl 0.9%)

• Hypertonic solution (NaCl 3%)

Locations

Country	Name	City	State
Italy	Pediatria, Azienda Ospedaliera Santa Maria Degli Angeli	Pordenone	Friuli Venezia Giulia
Italy	Emergency Department, IRCCS Burlo Garofolo	Trieste	Friuli Venezia Giulia

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen saturation (%)	Measurement of arterial oxygen saturation (SpO2) of hemoglobin with digital pulse oximeter	up to 50 minutes after allocation	No
Secondary	Respiratory effort (WARME score)	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).	5, 15, 20, 50 minutes after allocation	No