The Effectiveness of Nebulized Hypertonic Saline Solution for Acute Bronchiolitis

NCT02760719 | Terminated Phase 2

• 1 other identifier: 22k/12/12
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiolitis

Keywords

3% hypertonic solution; duration of hospitalisation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Duration of hospitalisation

  Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years

• Duration of hypoxia

  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

  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

  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)

  Through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time

Study Arms (2)

hypertonic saline

EXPERIMENTAL

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

supportive care

NO INTERVENTION

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

Interventions

nebulized 3% hypertonic solution DRUG

already described

hypertonic saline

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

Department of infectious disease, University Medical Centre, Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (3)

• 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.

  PMID: 23900970 RESULT

• 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.

  PMID: 25389139 RESULT

• 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.

  PMID: 26416925 RESULT

MeSH Terms

Conditions

Bronchiolitis

Interventions

Hypertonic Solutions

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Solutions; Pharmaceutical Preparations

Study Officials

• Tatjana Lejko Zupanc, MD, PhD

  University Medical Centre Ljubljana

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: May 4, 2016
• Study Start: December 1, 2015
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: August 5, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)