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

Study ID
STU 012013-040

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Amanda Lee
214-456-0195
amanda.lee@utsouthwestern.edu

Principal Investigator
Kresimir Aralica

Summary

The study will be a randomized, double-blind, controlled trial. Patients presenting to CMC emergency Department with signs or symptoms consistent with bronchiolitis will be assessed for eligibility. eligible patients will be patients 0-24 months of age with moderate to severe bronchiolitis. The severity of bronchiolitis will be assessed by eD respiratory therapists or pediatric emergency fellows using a respiratory distress assessment instrument (RDai) score. The RDai score is based on assessments of retractions and auscultatory findings; the sum of these scores provides the RDai score ranging from 0 to 17, with increasing scores indicating increasing respiratory distress.

all the respiratory therapists and pediatric emergency fellows in our emergency department are trained to use an RDai score and it is currently part of standard of care practice. if the respiratory score is initially assessed to be [GreaterThanorequalTo]6, and patients fulfill inclusion and exclusion criteria they will be approached by a member of a research team to be consented for enrollment. once consented, the study drug will be ordered by a physician at the request of a study team member. once the drug order set is received by a pharmacist, they will obtain the study drug from an omnicell and prepare the medication to a volume of 3mL 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. Treatments will be given by the standard nebulizer over the course of 15 minutes. Within 5-15 minutes following the intervention, the RDai score will be reassessed and study interventions are complete. The patient will be observed for one hour in the eD. if the patient is discharged home a third score will be assigned 60 minutes post intervention. all RDai scores will be assigned by the same person. However, further treatments may be started immediately upon discretion of the treating physician. Further treatments are not part of the study and would be given even in case the child was not enrolled in the study.
0.9% normal saline will be used as a control group because albuterol and Racemic epinephrine are prepared by mixing these preparations with 2.5ml of 0.9% normal saline so we can safely conclude that every patients with bronchiolitis inhaling those medication is also inhaling 2.5ml of normal saline with every administration and there were no benefits attributed none the less. The primary outcome variable will be Respiratory assessment Change Score (RCaS) which is a sum of the change in the 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 secondary outcome will be a rate of hospitalizations and return to the emergency department within 7 days for the patients discharged from the eD. 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.

Participant Eligibility

1. Children 0-24 months of age presenting to Children[Single Quote]s Medical Center x Dallas Emergency Department
2. Patients with a diagnosis of bronchiolitis defined as the first episode of wheezing and/or crackles in a child younger than 24 months who has physical findings of a viral respiratory infection and has no other explanation for the wheezing and/or crackles
3. Patients with an RDAI score >=6 as measured by a trained respiratory therapist and/or pediatric emergency medicine fellow