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Completed

NCT Number: NCT01238848

Efficacy of Nebulized Hypertonic Saline in the Treatment of Acute Bronchiolitis

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.

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Key information

Conditions

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

Age range

1 month–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital General de Niños Pedro de Elizalde

Buenos Aires, Buenos Aires F.D., C1270AAN, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hypertonic saline

Drug

3 cc nebulized hypertonic saline + albuterol 0.25 mg/kg/day, four times a day (QID), 5 days

Other names: ClNa 3% (sodium chloride 3%)

normal saline

Drug

3 cc nebulized normal saline + albuterol 0.25 mg/kg/day, four times a day (QID), 5 days

Other names: ClNa 0.9% (sodium chloride 0.9%)

Primary outcomes

  1. Hospitalization Days

    Time frame: Participants will be followed for the duration of hospitalization, an expected average of 4 days

    hospitalization days

Secondary outcomes

  1. Length of Oxygen Use

    Time frame: Participants will be followed for the duration of hospitalization, an expected average of 4 days

    Length of oxygen use (days)

Sponsors and collaborators

Lead sponsor

Hospital General de Niños Pedro de Elizalde

Other

Registry information

Official study title

A Randomized Controlled Trial to Evaluate Efficacy of Nebulized Hypertonic Saline vs. Normal Saline in the Treatment of Hospitalized Children With Bronchiolitis

Acronym: Hypertonic

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Nov 11, 2010
Registry last updated
Feb 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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