Efficacy of Nebulized Hypertonic Saline in the Treatment of Acute Bronchiolitis

Hospital General de Niños Pedro de Elizalde

Status: Completed

Conditions: Bronchiolitis

Treatments: Drug: Hypertonic saline; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01238848

HGNPE-14-2010

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of hypertonic saline vs. normal saline in the treatment of infants hospitalized for bronchiolitis, regarding length of hospital stay, oxygen requirements and clinical outcome.

Full description

Despite bronchiolitis is a very frequent disease among infants, there are still controversies regarding its treatment. Hypertonic saline has been proposed as useful treatment in these children, bur information is still controversial.

The aim is to asses that using Nebulized Hypertonic Saline with bronchodilators (albuterol) may reduce the days of hospitalization and improve clinical outcomes in patients with acute bronchiolitis, compared with using Normal Saline with albuterol.

Enrollment: 82 patients

Sex: All

Ages: 1 month to 2 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants aged 1 to 24 months, hospitalized for first episode of bronchiolitis, with severity score ≥ 5 points and oxygen saturation ≥ 97%.

Exclusion criteria

• Chronic respiratory or cardiovascular disease, respiratory failure.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

Hypertonic

Experimental group

Description:

Nebulized hypertonic saline (sodium chloride 3%) + albuterol

Treatment:

Drug: Hypertonic saline

Normal

Active Comparator group

Description:

Normal saline (sodium chloride 0.9%) + albuterol

Treatment:

Drug: Normal saline