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

This study has been completed.
Sponsor:
Information provided by:
Chongqing Medical University
ClinicalTrials.gov Identifier:
NCT01120496
First received: April 23, 2010
Last updated: May 10, 2010
Last verified: November 2008
  Purpose

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.


Condition Intervention
Bronchiolitis
Drug: 3% hypertonic saline
Drug: normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Nebulized Hypertonic Saline Treatment in Hospitalized Children With Moderate to Severe Viral Bronchiolitis

Resource links provided by NLM:


Further study details as provided by Chongqing Medical University:

Primary Outcome Measures:
  • To determine the efficacy of frequently nebulized HS in moderately to severely ill infants with bronchiolitis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Compare the wheezing remission time,Cough remission time,moist crackles disappeared time and the hospital length of stay between HS and NS.


Secondary Outcome Measures:
  • To determine the safety of frequently nebulized HS in moderately to severely ill infants with bronchiolitis [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    evaluated for the hoarse voice, vomiting, diarrhea, general condition


Enrollment: 135
Study Start Date: November 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: hypertonic saline
hypertonic saline (HS)
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
Other Names:
  • 3% hypertonic saline
  • normal saline
Placebo Comparator: normal saline (NS)
normal saline (NS)
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
Other Names:
  • 3% hypertonic saline
  • normal saline

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

  Eligibility

Ages Eligible for Study:   1 Month to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01120496

Sponsors and Collaborators
Chongqing Medical University
Investigators
Principal Investigator: zhengxiu luo, doctor Chongqing Medical University
  More Information

Additional Information:
No publications provided

Responsible Party: zhengxiu luo, Children's Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT01120496     History of Changes
Other Study ID Numbers: ChiCTR-TRC
Study First Received: April 23, 2010
Last Updated: May 10, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Chongqing Medical University:
Hypertonic saline solution, bronchiolitis, RSV

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis, Viral
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 01, 2014