Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis

N/ACompletedNCT02029040

University of Texas Southwestern Medical Center52 enrolled

Overview

This is a randomized, double-blind, controlled trial in the Pediatric Emergency Department. The primary objective is to determine whether nebulized 3% hypertonic saline is more effective than nebulized 0.9% saline in the treatment of bronchiolitis in the emergency department.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Acute Bronchiolitis

Interventions

3% Hypertonic SalineDRUG

Within 5-15 minutes following the administration of the study drug, the Respiratory Distress Assessment Instrument (RDAI) score will be reassessed and study interventions are complete. The patient will be observed for one hour in the emergency department (ED). However, further treatments may be started immediately upon discretion of the treating physician. If the patient is discharged home study PI and/or research assistant will call the parents 7 days from the ED visit to check the number of visits to their primary doctor and/or EDs due to same illness.

0.9 % normal salineDRUG

Eligibility

Sex: ALLMin age: 2 MonthsMax age: 12 Months

Medical Language ↔ Plain English

Inclusion Criteria: * Children 2-12 months of age presenting to Emergency Department * Patients with a diagnosis of bronchiolitis defined as the first episode of wheezing and/or crackles in a child younger than 12 months who has physical findings of a viral respiratory infection and has no other explanation for the wheezing and/or crackles * Patients with an RDAI score ≥ 6 as measured by a trained respiratory therapist Exclusion Criteria: * Previous history of wheezing * Known heart or lung disease * Premature birth defined as birth before 37 weeks gestation * Immunosuppression or immunodeficiency * Treatment with corticosteroids in the previous 48 hours * Critically ill children - progressive respiratory failure requiring higher level of care, vital signs instability/need for emergency interventions to prevent clinical deterioration * Oxygen saturation \<85% on room air at the time of recruitment

Locations (1)

UT Southwestern Medical Center; Children's Medical Center

Dallas, Texas, United States

Outcomes

Primary Outcomes

Respiratory Assessment Change Score (RACS)

The primary outcome variable is the Respiratory Assessment Change Score (RACS) which is a sum of the change in the Respiratory Distress Assessment Instrument (RDAI)score plus a standardized score for the change in respiratory rate; the change in respiratory rate is assigned 1 point per each 10% change in the respiratory rate.The RDAI score is the sum of the row scores, with total range 0 to 17; higher scores indicate more severe disease.

Time frame: 5-15 minutes

Secondary Outcomes

Rate of Hospitalizations

Time frame: 24 hours

Data from ClinicalTrials.gov

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