Status:

COMPLETED

Impact of Oximetry on Hospitalization in Acute Bronchiolitis

Lead Sponsor:

The Hospital for Sick Children

Conditions:

Bronchiolitis

Eligibility:

All Genders

6-12 years

Phase:

PHASE4

Brief Summary

To determine, in previously healthy infants 6 weeks to 12 months of age, diagnosed with acute bronchiolitis and monitored by hourly oximetry, if the probability of hospitalization within 72 hours of a...

Detailed Description

This is the first bronchiolitis study to examine the clinical and economic impact of making disposition decision on primarily clinical grounds, while blinding the physicians to oxygen saturations by p...

Eligibility Criteria

Inclusion

  • Acute bronchiolitis
  • Age 4 weeks to 12 months
  • Baseline Respiratory Disease Assessment Instrument (RDAI) ≥ 3 points
  • Informed consent
  • Availability of a telephone

Exclusion

  • Pre-existing pulmonary or cardiac distress, neuromuscular disease, congenital or acquired airway anomalies, hemoglobinopathies, or chronic hypoxia
  • Severe respiratory distress, defined as the retraction component on the RDAI as 8 out of possible 9 points
  • True baseline oxygen saturation less than 88% in room air
  • Transfers from other institutions

Key Trial Info

Start Date :

March 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2013

Estimated Enrollment :

213 Patients enrolled

Trial Details

Trial ID

NCT00673946

Start Date

March 1 2008

End Date

May 1 2013

Last Update

December 9 2013

Active Locations (1)

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1

The Hospital for Sick Children

Toronto, Ontario, Canada