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Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02029040
First Posted: January 7, 2014
Last Update Posted: May 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
  Purpose
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.

Condition Intervention
Acute Bronchiolitis Drug: 3% Hypertonic Saline versus 0.9 % normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis in The Emergency Department

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Respiratory Assessment Change Score (RACS) [ Time Frame: 15 minutes; one hour ]
    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


Secondary Outcome Measures:
  • Rate of Hospitalizations [ Time Frame: 24 hours ]
  • Return to Emergency Department [ Time Frame: 7 days ]

Enrollment: 52
Study Start Date: December 2013
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3% hypertonic saline group
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.
Drug: 3% Hypertonic Saline versus 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.
Placebo Comparator: 0.9% normal saline group
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.
Drug: 3% Hypertonic Saline versus 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02029040


Locations
United States, Texas
UT Southwestern Medical Center; Children's Medical Center
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Study Director: Mohamed Badawy, MD UT Southwestern Medical Center
  More Information

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02029040     History of Changes
Other Study ID Numbers: STU 012013-040
First Submitted: January 3, 2014
First Posted: January 7, 2014
Last Update Posted: May 4, 2016
Last Verified: May 2016

Keywords provided by University of Texas Southwestern Medical Center:
Bronchiolitis
Hypertonic saline
Emergency Department

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections


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