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The Effectiveness of Nebulized Hypertonic Saline Solution for Acute Bronchiolitis (NHSAB)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by University Medical Centre Ljubljana
Sponsor:
Information provided by (Responsible Party):
Tina Plankar Srovin, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:
NCT02760719
First received: April 6, 2016
Last updated: May 17, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention Phase
Bronchiolitis
Drug: nebulized 3% hypertonic solution
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effectiveness of Nebulized 3% Hypertonic Saline With Salbutamol in Acute Bronchiolitis in Hospitalised Children- a Randomized Clinical Trial

Further study details as provided by University Medical Centre Ljubljana:

Primary Outcome Measures:
  • Fit to discharge time [ Time Frame: Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years ]
    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.


Secondary Outcome Measures:
  • Duration of hospitalisation [ Time Frame: Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years ]
    Actual time to discharge in hours, which could be prolonged for other reasons than just bronchiolitis

  • Duration of hypoxia [ Time Frame: Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years ]
    For how long (in hours) participants need the oxygen therapy (have saturation on air bellow 92%).

  • Clinical severity score (CSS) assessed by Wang score [ Time Frame: Through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time ]
    Wang 1992 CSS as an outcome: measured two times daily

  • Number of participants with treatment related adverse events assessed by questionnaire [ Time Frame: Through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time ]
    To asses all possible side effects related to the inhalation of hypertonic saline

  • Number of participants transferred to the intensive care unit (ICU) [ Time Frame: Through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time ]
    The need to be transferred to the ICU because of the respiratory failure

  • Number of patients readmitted to the hospital because of the same diagnose [ Time Frame: Through study completion - estimated to 2 years; the patients will be assessed up to one month after discharge ]
    Rate of readmission within one month after discharge because of the same disease

  • Comparison of fit to discharge time between patients treated with nebulized hypertonic saline with respiratory syncytial virus (RSV) versus non-RSV bronchiolitis. [ Time Frame: Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years ]
    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).

  • Comparison of hypoxia duration between patients treated with nebulized hypertonic saline with respiratory syncytial virus (RSV) versus non-RSV bronchiolitis. [ Time Frame: Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years ]
    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.

  • Number of participants with treatment related adverse events assessed by questionnaire: comparison of patients with RSV bronchiolitis and patients with non-RSV bronchiolitis. [ Time Frame: through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time ]
    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.


Estimated Enrollment: 100
Study Start Date: December 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: hypertonic saline
4 ml of nebulized 3 % hypertonic saline + salbutamol 0,03 ml/kg every 8 hours for the time of hospitalisation and standard supportive care (oxygen to correct hypoxia, minimal handling to minimise the risk of exhaustion, provision of fluids, gentle nasal aspiration)
Drug: nebulized 3% hypertonic solution
already described
No Intervention: supportive care
Standard supportive care (oxygen to correct hypoxia, minimal handling to minimise the risk of exhaustion, provision of fluids, gentle nasal aspiration)

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

Ages Eligible for Study:   1 Month to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02760719

Contacts
Contact: Tina Plankar Srovin, MD, PhD +38615222621 tina.plankarsrovin@kclj.si
Contact: Simona Bizjak, MD +38615222110 simonabizjak@gmail.com

Locations
Slovenia
Department of infectious disease, University Medical Centre, Ljubljana Recruiting
Ljubljana, Slovenia, 1000
Contact: Tina Plankar Srovin, MD, PhD    +38615222621    tina.plankarsrovin@kclj.si   
Contact: Tatjana Lejko Zupanc, Md, PhD    +38615222110    tatjana.lejko@kclj.si   
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
Study Chair: Tatjana Lejko Zupanc, MD, PhD University Medical Centre Ljubljana
  More Information

Publications:
Responsible Party: Tina Plankar Srovin, MD, PhD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02760719     History of Changes
Other Study ID Numbers: 22k/12/12
Study First Received: April 6, 2016
Last Updated: May 17, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University Medical Centre Ljubljana:
3% hypertonic solution
duration of hospitalisation

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on May 25, 2017