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

NCT ID: NCT01120496

Last Updated: 2010-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2009-11-30

Brief 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.

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

Conditions

Bronchiolitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

hypertonic saline

hypertonic saline (HS)

Group Type: EXPERIMENTAL

3% hypertonic saline

Intervention Type: DRUG

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

normal saline (NS)

normal saline (NS)

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

normal saline; 3% hypertonic saline

Eligibility 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.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Children's Hospital of Chongqing Medical University

Principal Investigators

zhengxiu luo, doctor

Role: PRINCIPAL_INVESTIGATOR

Chongqing Medical University

Related Links

http://www.clinicaltrials.gov

Related Info

Other Identifiers

ChiCTR-TRC

Identifier Type: -

Identifier Source: org_study_id