The Effectiveness of Nebulized Hypertonic Saline Solution for Acute Bronchiolitis

• Status: Terminated
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the effectiveness of nebulized 3% hypertonic saline solution with salbutamol in the treatment of children under 2 years, hospitalised for acute viral bronchiolitis. Half of the participants will receive nebulized 3% hypertonic saline solution with salbutamol three times daily, the other half will receive standard supportive care, which is the cornerstone of the bronchiolitis management.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Centre Ljubljana
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• first episode of bronchiolitis: viral lower respiratory tract infection with signs of airway obstruction (hyperinflated lungs, tachypnea, increased work of breathing) and crepitations on auscultations

• admission to the hospital

• Wang CSS between 3 and 9

• randomisation within 4 hours of admission

Exclusion Criteria:

• a history or previous episodes of bronchiolitis/bronchitis

• primary diseases: gastro-oesophageal reflux, chronic cardiac or pulmonary diseases including suspected asthma, immunodeficiency, conditions with hypotonia where more severe course of bronchiolitis is expected

• newborns

• premature infants born < 36 weeks of gestation

• oxygen saturation < 85% and patients requiring admission to high dependency or intensive care units at presentation