Hypertonic Saline to Reduce Hospital Admissions in Bronchiolitis

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Inhaled 3% hypertonic saline (HS) administered every 2-8 hours to infants admitted to hospital with viral bronchiolitis has been shown to improve airway clearance and reduces length of stay.

Hypothesis: When infants first present to the ER, frequent administration of HS over a brief time period will provide significant symptom improvement such that the need for hospital admission will be reduced.

Objective: To determine in a randomized, controlled and double-blind fashion if the short term intensive use of inhaled 3% hypertonic saline (HS) in the Emergency Room (ER) can reduce the rate of hospital admission for infants presenting with moderately severe viral bronchiolitis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Queen's University
• Collaborators: Kingston General Hospital; Kingston Health Sciences Centre; Religious Hospitallers of Saint Joseph of the Hotel Dieu of Kingston; Royal Victoria Hospital Of Barrie
• Treatments: Albuterol; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

1. < 24 months.

2. presenting to ER or outpatient department with moderately severe viral bronchiolitis defined as:

1. history of viral upper respiratory tract infection within previous 7 days, plus

2. presence of wheezing and/or crackles on chest auscultation, plus

3. Respiratory Distress Assessment Instrument (RDAI, appendix B) score > 4 (of 17) or transcutaneous oxygen saturation (SaO2) < 94% in room air.

Patient exclusion criteria:

1. history of immunodeficiency or chronic cardiopulmonary disease (other than past history of wheezing).

2. critical illness at presentation.

3. use of nebulized HS within previous 12 hr.

4. prematurity (gestational age < 34 weeks).