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Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Texas Southwestern Medical Center
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT02029040
First received: January 3, 2014
Last updated: January 7, 2014
Last verified: January 2014
  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: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Return to Emergency Department [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2013
Estimated 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

Ages Eligible for Study:   2 Months to 12 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02029040

Contacts
Contact: Mohamed Badawy, MD 214-456-7106 Mohamed.Badawy@utsouthwestern.edu
Contact: Kresimir Aralica, MD 214-456-6371 Kresimir.Aralica@utsouthwestern.edu

Locations
United States, Texas
UT Southwestern Medical Center; Children's Medical Center Recruiting
Dallas, Texas, United States, 75235
Contact: Mohamed Badawy, MD    214-456-7106    Mohamed.Badawy@utsouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Study Director: Mohamed Badawy, MD UT Southwestern Medical Center
  More Information

No publications provided

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02029040     History of Changes
Other Study ID Numbers: STU 012013-040
Study First Received: January 3, 2014
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 20, 2014