A Study of Hypertonic Saline for Infants Hospitalized With Bronchiolitis

Bronchiolitis Clinical Trial

Official title:

A Double-Blind, Controlled, Randomized Clinical Trial of Nebulized Hypertonic Saline for Hospitalized Infants With Viral Bronchiolitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01488448
• Other study ID #: 11-09-329
• Status: Completed
• Phase: N/A
• First received: December 2, 2011
• Last updated: January 31, 2017
• Start date: November 2011
• Est. completion date: August 2015

Study information

• Verified date: January 2017
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if nebulized hypertonic saline (or extra salty water mist) helps infants less than 12 months old hospitalized with bronchiolitis (or bad chest colds) get better enough to be discharged from the hospital sooner than those infants given nebulized normal saline (or regular salty water mist).

Description:

Bronchiolitis is a common admitting diagnosis for children less than 1 year of age. Although bronchiolitis has a high prevalence, there is a lack of a unified inpatient treatment plan beyond supportive care of supplemental oxygen and intravenous hydration. There have been many different approaches to the treatment of bronchiolitis, but none have conclusively proven to be beneficial. Several early studies show promise for the use of nebulized hypertonic saline, however the majority of these studies are done outside the United States and with adjunctive therapy. To date, the data suggesting that nebulized hypertonic saline is safe and effective for reducing length of stay in bronchiolitis is strong but not generalizable for the United States. The objective of this study is to conduct the first double-blind, randomized controlled trial in the United States of nebulized hypertonic saline without adjunctive therapy, including infants with bronchiolitis, including those with prior history of wheeze, to assess the effect on length of stay and therefore resource utilization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: August 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 12 Months

Eligibility

Inclusion Criteria:

• Patients 0-12 months of age admitted to the hospital with a diagnosis of bronchiolitis.

Exclusion Criteria:

• status asthmaticus

• chronic cardiopulmonary disease

• Trisomy 21

• immunodeficiency or transplant recipient

• neuromuscular disease

• admission directly to the intensive care unit

• previous use of nebulized hypertonic saline less than 12 hours prior to presentation

• previous enrollment in the study in the 72 hours prior to presentation

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

Drug:
• 3% sodium chloride
4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge
• 0.9% sodium chloride
4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge

Locations

Country	Name	City	State
United States	Children's Hospital at Montefiore	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of Stay in the Study-LOS--Intention to Treat Analysis	Length of stay will be defined by the duration between the time of first study treatment to the time a discharge order is placed. Alternatively, if a patient remains inpatient for other, non-bronchiolitis related reasons (i.e. social reasons, etc.) the time a patient could be discharged from the standpoint of bronchiolitis as documented by the attending, will be used.	Time of first study treatment until time of discharge
Primary	Length of Stay in the Study-LOS by Per Protocol Analysis	Length of stay will be defined by the duration between the time of first study treatment to the time a discharge order is placed. Alternatively, if a patient remains inpatient for other, non-bronchiolitis related reasons (i.e. social reasons, etc.) the time a patient could be discharged from the standpoint of bronchiolitis as documented by the attending, will be used.	Time of first study treatment until time of discharge
Secondary	Readmission for Bronchiolitis Within 7 Days of Discharge	Phone call at 7 days to assess for readmission to any hospital	within 7 days of hospital discharge
Secondary	Clinical Worsening	transfer to the Pediatric Intensive Care Unit (PICU) (including withdrawn from the study for bronchodilator administration who were then transferred to the PICU), or Respiratory Distress Assessment Instrument (RDAI) increase of 4 or more points within 30 minutes of a study treatment	though hospitalization/time period receiving study treatment, average 2-3 days
Secondary	Total Adverse Events	Clinical worsening events (defined prior) + 7 day readmissions	Time of enrollment in the study through 1 week after hospital discharge