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

Overview

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.

Full Title of Study: “A Randomized Controlled Trial of Nebulized Hypertonic Saline Treatment in Hospitalized Children With Moderate to Severe Viral Bronchiolitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 2009

Detailed Description

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

Interventions

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

Arms, Groups and Cohorts

  • Experimental: hypertonic saline
    • hypertonic saline (HS)
  • Placebo Comparator: normal saline (NS)
    • normal saline (NS)

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 1 Month

Maximum Age: 24 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chongqing Medical University
  • Provider of Information About this Clinical Study
    • zhengxiu luo, Children’s Hospital of Chongqing Medical University
  • Overall Official(s)
    • zhengxiu luo, doctor, Principal Investigator, Chongqing Medical University

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