Randomized Controlled Trial to Evaluate the Efficacy of Nasal Irrigation in Infants With Bronchiolitis
Overview
- Phase
- Phase 3
- Intervention
- Isotonic solution (NaCl 0.9%)
- Conditions
- Bronchiolitis
- Sponsor
- IRCCS Burlo Garofolo
- Enrollment
- 133
- Locations
- 2
- Primary Endpoint
- Oxygen saturation (%)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Ronfani Luca
MD, PhD
IRCCS Burlo Garofolo
Eligibility Criteria
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
Arms & Interventions
Isotonic solution (NaCl 0.9%)
Single nasal irrigation with 1 ml of isotonic solution (NaCl 0.9%) per each nostril
Intervention: Isotonic solution (NaCl 0.9%)
Hypertonic solution (NaCl 3%)
Single nasal irrigation with 1 ml of hypertonic solution (NaCl 3%) per each nostril
Intervention: Hypertonic solution (NaCl 3%)
Outcomes
Primary Outcomes
Oxygen saturation (%)
Time Frame: up to 50 minutes after allocation
Measurement of arterial oxygen saturation (SpO2) of hemoglobin with digital pulse oximeter
Secondary Outcomes
- Respiratory effort (WARME score)(5, 15, 20, 50 minutes after allocation)