Effectiveness of nebulized mild hypertonic saline solution in children with mild-to-moderate RSV bronchiolitis: randomized, open-label, active-control intervention study
Mild-to-moderate RSV (respiratory syncytial virus) bronchiolitis
The study interventions will include: - Investigational medical device: Sinomarin® Babies single use vials, hypertonic saline (2.3 % NaCl), 5 mL, nebulized inhalations. - Comparator medical device: Physiodose, 0.9 % NaCl, 5 mL vials, Laboratoires Gilbert, nebulized inhalations. Both medical device products have marketing authorization in the EU. Patients with mild to moderate RSV bronchiolitis (Wang score 3-8) will be randomized in two groups: Group 1: Infants receiving standard nebulized medication and nebulized 0.9 % NaCl (Physiodose) Group 2: Infants receiving standard nebulized medication and nebulized 2.3 % NaCl (Sinomarin Babies) A block randomization method will be used to stratify patients into blocks of 3 each, each comprising of 3 patients. The 2:1 sequence of administration will be assigned to the subject by randomization module implemented to the study eCRF. Treatments will be administered as follows: Day 1: 2 hospital nebulization sessions and 2 home nebulization sessions Days 2-6: 1 hospital nebulization session and 2 home nebulization sessions Day 7: treatment as needed Each nebulization comprises a first nebulization of standard medication (bronchodilator) followed by saline nebulization.
Previously healthy children visiting the Emergency Room (ER) and Day Care Department (DCD) with the following inclusion criteria will be recruited: 1. Age between 4 weeks and 2 years 2. First episode of wheezing 3. History of upper viral respiratory tract infection (symptoms of coryza, cough or fever) 4. Children with mild-to-moderate disease as evaluated with the Wang score between 3 and 8
1. Any underlying disease, comorbidity or congenital malformation (e.g., cystic fibrosis, bronchopulmonary dysplasia, cardiac or renal disease, etc) 2. Prior history of wheezing or asthma 3. Children with severe disease as evaluated with the Wang score (>8) 4. Children with progressive respiratory distress requiring mechanical ventilation 5. Previous treatment with bronchodilators (within the last 4 h), steroids (within 48 h), or nebulized saline solutions (within 12 h)