Clinical trial NCT02760719: The Effectiveness of Nebulized Hypertonic Saline Solution for Acute Bronchiolitis
Official title: The Effectiveness of Nebulized 3% Hypertonic Saline With Salbutamol in Acute Bronchiolitis in Hospitalised Children- a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Bronchiolitis
Keywords: 3% hypertonic solution
duration of hospitalisation
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2016-05-04
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Acute viral bronchiolitis is the most common lower respiratory tract infection in infants up to two years old. Currently there is no effective treatment so standard treatment remains supportive care with supplemental oxygen to correct hypoxia, minimal handling to minimise the risk of exhaustion and the provision of fluids.

In recent years some studies have suggested that nebulised hypertonic saline, which improve airway hygiene, may influence the course of the illness and reduce the duration of hospitalisation without significant side effects.

Study protocol: half of the included patients will receive standard treatment for bronchiolitis, which includes only supportive care, the other half will additionally receive nebulized 3% hypertonic saline solution with salbutamol (to avoid potential bronchial obstruction) three times daily.

Eligibility 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

Primary outcomes:
measure: Fit to discharge time
timeFrame: Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
Secondary outcomes:
measure: Duration of hospitalisation
timeFrame: Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
measure: Duration of hypoxia
timeFrame: Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
measure: Clinical severity score (CSS) assessed by Wang score
timeFrame: Through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time
measure: Number of participants with treatment related adverse events assessed by questionnaire
timeFrame: Through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time
measure: Number of participants transferred to the intensive care unit (ICU)
timeFrame: Through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time
measure: Number of patients readmitted to the hospital because of the same diagnose
timeFrame: Through study completion - estimated to 2 years; the patients will be assessed up to one month after discharge
measure: Comparison of fit to discharge time between patients treated with nebulized hypertonic saline with respiratory syncytial virus (RSV) versus non-RSV bronchiolitis.
timeFrame: Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
measure: Comparison of hypoxia duration between patients treated with nebulized hypertonic saline with respiratory syncytial virus (RSV) versus non-RSV bronchiolitis.
timeFrame: Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
measure: Number of participants with treatment related adverse events assessed by questionnaire: comparison of patients with RSV bronchiolitis and patients with non-RSV bronchiolitis.
timeFrame: through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Department of infectious disease, University Medical Centre, Ljubljana
Study officials:
affiliation: University Medical Centre Ljubljana
name: Tatjana Lejko Zupanc, MD, PhD
role: STUDY_CHAIR
References:
citation: Zhang L, Mendoza-Sassi RA, Wainwright C, Klassen TP. Nebulised hypertonic saline solution for acute bronchiolitis in infants. Cochrane Database Syst Rev. 2013 Jul 31;(7):CD006458. doi: 10.1002/14651858.CD006458.pub3.
citation: Everard ML, Hind D, Ugonna K, Freeman J, Bradburn M, Cooper CL, Cross E, Maguire C, Cantrill H, Alexander J, McNamara PS; SABRE Study Team. SABRE: a multicentre randomised control trial of nebulised hypertonic saline in infants hospitalised with acute bronchiolitis. Thorax. 2014 Dec;69(12):1105-12. doi: 10.1136/thoraxjnl-2014-205953.
citation: Zhang L, Mendoza-Sassi RA, Klassen TP, Wainwright C. Nebulized Hypertonic Saline for Acute Bronchiolitis: A Systematic Review. Pediatrics. 2015 Oct;136(4):687-701. doi: 10.1542/peds.2015-1914.