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

Chongqing Medical University

Status: Completed

Conditions: Bronchiolitis

Treatments: Drug: normal saline; Drug: 3% hypertonic saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01120496

ChiCTR-TRC

Details and patient eligibility

About

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 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

Enrollment: 135 patients

Sex: All

Ages: 1 to 24 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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135 participants in 2 patient groups, including a placebo group

hypertonic saline

Experimental group

Description:

hypertonic saline (HS)

Treatment:

Drug: 3% hypertonic saline

normal saline (NS)

Placebo Comparator group

Description:

normal saline (NS)

Treatment:

Drug: normal saline