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Hypertonic Saline to Reduce Hospital Admissions in Bronchiolitis

NCT00677729 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2015-11-13

No results posted yet for this study

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.

Conditions

  • Viral Bronchiolitis

Interventions

DRUG

solution contains 1 mg salbutamol plus 3% hypertonic saline

4 ml of nebulized study solution containing 1 mg salbutamol plus 3% hypertonic saline every 20 minutes for a total of 3 doses

DRUG

solution contains 1 mg salbutamol plus 0.9% saline

4 ml of nebulized study solution containing 1 mg salbutamol plus 0.9% saline (NaCl) every 20 minutes for a total of 3 doses

Sponsors & Collaborators

  • Kingston Health Sciences Centre

    collaborator OTHER

  • Religious Hospitallers of Saint Joseph of the Hotel Dieu of Kingston

    collaborator UNKNOWN

  • Royal Victoria Hospital Of Barrie

    collaborator UNKNOWN

  • Queen's University

    lead OTHER

Principal Investigators

  • Brian Kuzik, MD · The Royal Victoria Hospital of Barrie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-04-30
Completion
2009-05-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00677729 on ClinicalTrials.gov