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

Bronchiolitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01120496
• Other study ID #: ChiCTR-TRC
• Status: Completed
• Phase: N/A
• First received: April 23, 2010
• Last updated: May 10, 2010
• Start date: November 2008
• Est. completion date: November 2009

Study information

• Verified date: November 2008
• Source: Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 24 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchiolitis, Viral

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the efficacy of frequently nebulized HS in moderately to severely ill infants with bronchiolitis	Compare the wheezing remission time,Cough remission time,moist crackles disappeared time and the hospital length of stay between HS and NS.	1 year	No
Secondary	To determine the safety of frequently nebulized HS in moderately to severely ill infants with bronchiolitis	evaluated for the hoarse voice, vomiting, diarrhea, general condition	1 year	Yes

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