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

August 1, 2019 updated by: Tina Plankar Srovin, University Medical Centre Ljubljana

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Department of infectious disease, University Medical Centre, Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
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%).
Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
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
Through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time
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
Through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time
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
Through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time
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
Through study completion - estimated to 2 years; the patients will be assessed up to one month after discharge
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).
Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
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.
Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
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.
through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Investigators

  • Study Chair: Tatjana Lejko Zupanc, MD, PhD, University Medical Centre Ljubljana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

April 6, 2016

First Submitted That Met QC Criteria

April 29, 2016

First Posted (Estimate)

May 4, 2016

Study Record Updates

Last Update Posted (Actual)

August 5, 2019

Last Update Submitted That Met QC Criteria

August 1, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22k/12/12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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