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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01120496

Enrollment

135

Registered

2010-05-11

Start date

2008-11-30

Completion date

2009-11-30

Last updated

2010-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis

Keywords

Hypertonic saline solution, bronchiolitis, RSV

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

Interventions

DRUG3% hypertonic saline

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

DRUGnormal saline

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Months to 24 Months

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.

Design outcomes

Primary

Measure	Time frame	Description
To determine the efficacy of frequently nebulized HS in moderately to severely ill infants with bronchiolitis	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

Measure	Time frame	Description
To determine the safety of frequently nebulized HS in moderately to severely ill infants with bronchiolitis	1 year	evaluated for the hoarse voice, vomiting, diarrhea, general condition

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026