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

University Medical Centre Ljubljana

Status and phase: Terminated; Phase 2

Conditions: Bronchiolitis

Treatments: Drug: nebulized 3% hypertonic solution

Study type: Interventional

Funder types: Other

Identifiers

NCT02760719

22k/12/12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 1 to 24 months old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

hypertonic saline

Experimental group

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)

Treatment:

Drug: nebulized 3% hypertonic solution

supportive care

No Intervention group

Description:

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