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Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis

Primary Purpose

Acute Bronchiolitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3% Hypertonic Saline
0.9 % normal saline
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Bronchiolitis focused on measuring Bronchiolitis, Hypertonic saline, Emergency Department

Eligibility Criteria

2 Months - 12 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UT Southwestern Medical Center; Children's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

3% hypertonic saline group

0.9% normal saline group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Rate of Hospitalizations

Full Information

First Posted
January 3, 2014
Last Updated
January 24, 2019
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02029040
Brief Title
Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis
Official Title
A Randomized Trial of Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis in The Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bronchiolitis
Keywords
Bronchiolitis, Hypertonic saline, Emergency Department

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3% hypertonic saline group
Arm Type
Experimental
Arm Description
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.
Arm Title
0.9% normal saline group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
3% Hypertonic Saline
Other Intervention Name(s)
Experimental
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
0.9 % normal saline
Other Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Respiratory Assessment Change Score (RACS)
Description
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 Outcome Measure Information:
Title
Rate of Hospitalizations
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Badawy, MD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
UT Southwestern Medical Center; Children's Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

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Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis

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