Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis

Not Applicable

Completed

• Conditions: Acute Bronchiolitis
• Interventions: Drug: 3% Hypertonic Saline; Drug: 0.9 % normal saline

• Registration Number: NCT02029040
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-01-03
• Study First Submitted QC: 2014-01-03
• Study First Posted: 2014-01-07
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2018-12-31
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-24
• Last Update Submitted: 2019-01-24
• Results First Posted: 2019-01-25
• Last Update Posted: 2019-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3% hypertonic saline group	3% Hypertonic Saline	Once consented, the study drug (in this arm: 3% Hypertonic Saline) will be ordered by a physician at the request of a study team member. Once the drug order set is received by a pharmacist, he/she will obtain the study drug from an Omnicell and prepare the medication to a volume of 3 mL in a syringe with a blinded study label prepared in advance by the IDS pharmacy. The pharmacist will then give the study drug to the patient's respiratory therapist or the bedside nurse. The respiratory therapist or the nurse will pour the drug from a syringe to an inhaler cup and the study drug will be given by the standard nebulizer over the course of 15 minutes.
0.9% normal saline group	0.9 % normal saline	Once consented, the study drug (in this arm: 0.9% normal saline) will be ordered by a physician at the request of a study team member. Once the drug order set is received by a pharmacist, he/she will obtain the study drug from an Omnicell and prepare the medication to a volume of 3 mL in a syringe with a blinded study label prepared in advance by the IDS pharmacy. The pharmacist will then give the study drug to the patient's respiratory therapist or the bedside nurse. The respiratory therapist or the nurse will pour the drug from a syringe to an inhaler cup and the study drug will be given by the standard nebulizer over the course of 15 minutes.

Primary Outcome Measures

Name	Time	Method
Respiratory Assessment Change Score (RACS)	5-15 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Rate of Hospitalizations	24 hours

Trial Locations

Locations (1)

UT Southwestern Medical Center; Children's Medical Center; 🇺🇸 Dallas, Texas, United States