The Effectiveness of Nebulized Hypertonic Saline Solution for Acute Bronchiolitis

Bronchiolitis Clinical Trial

— NHSAB  

Official title:

The Effectiveness of Nebulized 3% Hypertonic Saline With Salbutamol in Acute Bronchiolitis in Hospitalised Children- a Randomized Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02760719
• Other study ID #: 22k/12/12
• Status: Terminated
• Phase: Phase 2
• Start date: December 2015
• Est. completion date: July 2019

Study information

• Verified date: August 2019
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

Drug:
• nebulized 3% hypertonic solution
already described

Locations

Country	Name	City	State
Slovenia	Department of infectious disease, University Medical Centre, Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

References & Publications (3)

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 bro — View 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. Review. Erratum in: Pediatrics. 2016 Apr;137(4):. — View 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. Review. Update in: Cochrane Database S — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fit to discharge time	Fit to discharge time: as the point (measured in hours) at which the infant was feeding adequately (taking >75% of their usual intake) and had been in air with a saturation of at least 92% for 6 h.	Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
Secondary	Duration of hospitalisation	Actual time to discharge in hours, which could be prolonged for other reasons than just bronchiolitis	Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
Secondary	Duration of hypoxia	For how long (in hours) participants need the oxygen therapy (have saturation on air bellow 92%).	Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
Secondary	Clinical severity score (CSS) assessed by Wang score	Wang 1992 CSS as an outcome: measured two times daily	Through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time
Secondary	Number of participants with treatment related adverse events assessed by questionnaire	To asses all possible side effects related to the inhalation of hypertonic saline	Through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time
Secondary	Number of participants transferred to the intensive care unit (ICU)	The need to be transferred to the ICU because of the respiratory failure	Through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time
Secondary	Number of patients readmitted to the hospital because of the same diagnose	Rate of readmission within one month after discharge because of the same disease	Through study completion - estimated to 2 years; the patients will be assessed up to one month after discharge
Secondary	Comparison of fit to discharge time between patients treated with nebulized hypertonic saline with respiratory syncytial virus (RSV) versus non-RSV bronchiolitis.	To see if there are any differences in fit to discharge time (the point measured in hours at which the infant was feeding adequately - taking >75% of their usual intake and had been in air with a saturation of at least 92% for 6 h) between patients who received nebulized hypertonic saline and have RSV bronchiolitis and patients who received nebulized hypertonic saline and have non-RSV bronchiolitis (to see if hypertonic saline has better effect on fit to discharge time in patients who have RSV bronchiolitis compared to patients who have non-RSV bronchiolitis).	Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
Secondary	Comparison of hypoxia duration between patients treated with nebulized hypertonic saline with respiratory syncytial virus (RSV) versus non-RSV bronchiolitis.	To see if there are any differences in hypoxia (for how long in hours participants need the oxygen therapy: have saturation bellow 92%) between patients who received nebulized hypertonic saline and have RSV bronchiolitis and patients who received nebulized hypertonic saline and have non-RSV bronchiolitis.	Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
Secondary	Number of participants with treatment related adverse events assessed by questionnaire: comparison of patients with RSV bronchiolitis and patients with non-RSV bronchiolitis.	To asses all possible side effects related to the inhalation of hypertonic saline in patients who have RSV bronchiolitis compared to the patients who have non-RSV bronchiolitis.	through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time