Mild-to-moderate RSV (respiratory syncytial virus) bronchiolitis Infections and Infestations
Conditions
Interventions
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: P
Sponsors
Gerolymatos International SA
Eligibility
Sex/Gender
All
Age
4 Weeks to 24 Months
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The severity of bronchiolitis measured using the Wang Clinical Severity Score (WBSS) each day and from baseline to day 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 15/11/2024: 1. Changes in the following parameters were recorded from Baseline to Day 1 (i.e. after 2 h): clinical severity score using Wang Clinical Severity Score (WCSS) measurements, temperature using a thermometer, respiratory rate measured by recording the number of breaths per minute, SpO2 determined by pulse oximetry and heart rate measured with a heart monitor. 2. Changes in the following parameters were recorded from Baseline to Day 7: clinical severity score using Wang Clinical Severity Score (WCSS) measurements, temperature using a thermometer, respiratory rate measured by recording the number of breaths per minute, SpO2 determined by pulse oximetry and heart rate measured with a heart monitor. 3. Discharge and hospital admission rates were recorded after 2 h of observation of Day 1 and over the complete 7-day treatment period 4. Persistent cough, number of unscheduled visits and number of lost days of work of caregivers were recorded during the complete 7-day treatment period 5. Adverse events number, severity, and association with treatment were recorded during the complete 7-day treatment period 6. Expiratory variability index (EVI) measurements using the Ventica® device as recorded overnight on Days 1 to 2, Days 4 to 5 and Days 6 to 7. Previous secondary outcome measures: 1. Changes in clinical severity score, temperature, respiratory rate, SpO2 and heart rate (Timepoint: Baseline to Day 1 i.e. after 2 h) 2. Changes in clinical severity score, temperature, respiratory rate, SpO2 and heart rate 2 (Timepoint: Baseline to Day 7) 3. Discharge rate and hospital admission rate (Timepoint: after 2 h of observation of day 1 and over the complete 7-day treatment period) 4. Persistent cough, number of unscheduled visits and number of lost days of work of caregivers (Timepoint: complete 7-day treatment period) 5. Adverse events number, severity, association with treatment (Timepoint: complete 7-day treatment period) 6. | — |
Countries
Croatia
Contacts
Public ContactKonstantinos Alevizopoulos
Outcome results
None listed