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Completed

NCT Number: NCT01120496

Nebulized Hypertonic Saline Treatment in Hospitalized Children With Moderate to Severe Viral Bronchiolitis

The purpose of this study is planned to investigate whether frequently inhaled hypertonic saline (HS) can relieve symptoms and signs faster than normal saline (NS) and shorten length of stay (LOS) significantly for moderately to severely ill infants with bronchiolitis without apparent adverse effects.

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Key information

Age range

1 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The treatment of bronchiolitis remains largely supportive with mechanical ventilatory support as needed .Other types of treatment remain controversial.We and other researchers have demonstrated that nebulized HS and bronchodilators decreased symptoms and LOS for infants with mild to moderate viral bronchiolitis .All the aforementioned studies used 3 times per day dosing, which is significantly less than the 3 to 6 times per hour regimens often used in children in respiratory distress.Frequently nebulized HS reduced the LOS for infants with moderately severe bronchiolitis.The present study is planned to investigate whether frequently inhaled HS can relieve symptoms and signs faster than NS and shorten LOS significantly for moderately to severely ill infants with bronchiolitis without apparent adverse effects.

PMID: 15266547 PMID: 12576370 PMID: 16599051 PMID: 17719935 PMID: 20014350 PMID: 12475841

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • infants less than 24 months of age with first episode of wheezing.

Exclusion criteria

  • age>24 months,
  • previous episode of wheezing,
  • chronic cardiac and pulmonary disease,
  • immunodeficiency,
  • accompanying respiratory failure,
  • requiring mechanical ventilation,
  • inhaling the nebulized 3% hypertonic saline solution 12 hours before treatment,
  • premature infants born at less than 34 weeks gestation.

Treatment and study plan

3% Hypertonic saline

Drug

Moderately to severely ill infants with bronchiolitis were randomized to receive 4 mL solution containing either 3% hypertonic saline or normal saline

Other names: normal saline

normal saline

Drug

Moderately to severely ill infants with bronchiolitis were randomized to receive 4 mL solution containing either 3% hypertonic saline or normal saline

Other names: 3% hypertonic saline

Primary outcomes

  1. To determine the efficacy of frequently nebulized HS in moderately to severely ill infants with bronchiolitis

    Time frame: 1 year

    Compare the wheezing remission time,Cough remission time,moist crackles disappeared time and the hospital length of stay between HS and NS.

Secondary outcomes

  1. To determine the safety of frequently nebulized HS in moderately to severely ill infants with bronchiolitis

    Time frame: 1 year

    evaluated for the hoarse voice, vomiting, diarrhea, general condition

Sponsors and collaborators

Lead sponsor

Chongqing Medical University

Other

Registry information

Official study title

A Randomized Controlled Trial of Nebulized Hypertonic Saline Treatment in Hospitalized Children With Moderate to Severe Viral Bronchiolitis

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 11, 2010
Registry last updated
May 11, 2010

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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