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

Primary Purpose

Bronchiolitis

Status
Terminated
Phase
Phase 2
Locations
Slovenia
Study Type
Interventional
Intervention
nebulized 3% hypertonic solution
Sponsored by
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis focused on measuring 3% hypertonic solution, duration of hospitalisation

Eligibility Criteria

1 Month - 24 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of infectious disease, University Medical Centre, Ljubljana

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

hypertonic saline

supportive care

Arm Description

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)

Standard supportive care (oxygen to correct hypoxia, minimal handling to minimise the risk of exhaustion, provision of fluids, gentle nasal aspiration)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Duration of hospitalisation
Actual time to discharge in hours, which could be prolonged for other reasons than just bronchiolitis
Duration of hypoxia
For how long (in hours) participants need the oxygen therapy (have saturation on air bellow 92%).
Clinical severity score (CSS) assessed by Wang score
Wang 1992 CSS as an outcome: measured two times daily
Number of participants with treatment related adverse events assessed by questionnaire
To asses all possible side effects related to the inhalation of hypertonic saline
Number of participants transferred to the intensive care unit (ICU)
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
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.
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.
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.
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.

Full Information

First Posted
April 6, 2016
Last Updated
August 1, 2019
Sponsor
University Medical Centre Ljubljana
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1. Study Identification

Unique Protocol Identification Number
NCT02760719
Brief Title
The Effectiveness of Nebulized Hypertonic Saline Solution for Acute Bronchiolitis
Acronym
NHSAB
Official Title
The Effectiveness of Nebulized 3% Hypertonic Saline With Salbutamol in Acute Bronchiolitis in Hospitalised Children- a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
No relevant data
Study Start Date
December 2015 (undefined)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
3% hypertonic solution, duration of hospitalisation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hypertonic saline
Arm Type
Experimental
Arm Description
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)
Arm Title
supportive care
Arm Type
No Intervention
Arm Description
Standard supportive care (oxygen to correct hypoxia, minimal handling to minimise the risk of exhaustion, provision of fluids, gentle nasal aspiration)
Intervention Type
Drug
Intervention Name(s)
nebulized 3% hypertonic solution
Intervention Description
already described
Primary Outcome Measure Information:
Title
Fit to discharge time
Description
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.
Time Frame
Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
Secondary Outcome Measure Information:
Title
Duration of hospitalisation
Description
Actual time to discharge in hours, which could be prolonged for other reasons than just bronchiolitis
Time Frame
Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
Title
Duration of hypoxia
Description
For how long (in hours) participants need the oxygen therapy (have saturation on air bellow 92%).
Time Frame
Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
Title
Clinical severity score (CSS) assessed by Wang score
Description
Wang 1992 CSS as an outcome: measured two times daily
Time Frame
Through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time
Title
Number of participants with treatment related adverse events assessed by questionnaire
Description
To asses all possible side effects related to the inhalation of hypertonic saline
Time Frame
Through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time
Title
Number of participants transferred to the intensive care unit (ICU)
Description
The need to be transferred to the ICU because of the respiratory failure
Time Frame
Through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time
Title
Number of patients readmitted to the hospital because of the same diagnose
Description
Rate of readmission within one month after discharge because of the same disease
Time Frame
Through study completion - estimated to 2 years; the patients will be assessed up to one month after discharge
Title
Comparison of fit to discharge time between patients treated with nebulized hypertonic saline with respiratory syncytial virus (RSV) versus non-RSV bronchiolitis.
Description
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).
Time Frame
Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
Title
Comparison of hypoxia duration between patients treated with nebulized hypertonic saline with respiratory syncytial virus (RSV) versus non-RSV bronchiolitis.
Description
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.
Time Frame
Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
Title
Number of participants with treatment related adverse events assessed by questionnaire: comparison of patients with RSV bronchiolitis and patients with non-RSV bronchiolitis.
Description
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.
Time Frame
through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tatjana Lejko Zupanc, MD, PhD
Organizational Affiliation
University Medical Centre Ljubljana
Official's Role
Study Chair
Facility Information:
Facility Name
Department of infectious disease, University Medical Centre, Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23900970
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.
Results Reference
result
PubMed Identifier
25389139
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.
Results Reference
result
PubMed Identifier
26416925
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. Erratum In: Pediatrics. 2016 Apr;137(4):
Results Reference
result

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The Effectiveness of Nebulized Hypertonic Saline Solution for Acute Bronchiolitis

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