Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis

Acute Bronchiolitis Clinical Trial

Official title:

A Randomized Trial of Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis in The Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02029040
• Other study ID #: STU 012013-040
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: December 2014

Study information

• Verified date: January 2019
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Acute Bronchiolitis
• Bronchiolitis

Intervention

Drug:
• 3% Hypertonic Saline
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 saline
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.

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center; Children's Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5-15 minutes
Secondary	Rate of Hospitalizations		24 hours