The Effectiveness of Nebulized Hypertonic Saline Solution for Acute Bronchiolitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2019-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Nebulised Hypertonic Saline (3%) Among Children With Bronchiolitis.

NCT01276821

Bronchiolitis

COMPLETED PHASE4

Hypertonic Saline for Acute Bronchiolitis

NCT01247064

Bronchiolitis, Viral Saline Solution, Hypertonic

COMPLETED PHASE4

Nebulized 3% Hypertonic Saline Versus Normal Saline in Managing Children With Acute Bronchiolitis: A Randomized Controlled Trial

NCT07138625

Acute Bronchiolitis

NOT_YET_RECRUITING NA

Nebulized 3% Hypertonic Saline Solution Treatment of Bronchiolitis in Infants

NCT02233985

Bronchiolitis Wheezing

COMPLETED PHASE4

Nebulised 3% Hypertonic Saline Versus 0.9% Saline for Treating Patients Hospitalized With Acute Bronchiolitis

NCT06069336

Bronchiolitis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bronchiolitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

Group Type EXPERIMENTAL

nebulized 3% hypertonic solution

Intervention Type DRUG

already described

supportive care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

nebulized 3% hypertonic solution

already described

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

1 Month

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No