Status:

COMPLETED

Prediction of Extubation Readiness in Extreme Preterm Infants by the Automated Analysis of CardioRespiratory Behavior

Lead Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborating Sponsors:

Canadian Institutes of Health Research (CIHR)

Wayne State University

Conditions:

Prediction of Extubation Readiness

Eligibility:

All Genders

Brief Summary

The investigators hypothesize that machine learning methods using a combination of novel, quantitative measures of cardio-respiratory variability can accurately predict the optimal time to extubate ex...

Detailed Description

At birth, extreme preterm infants (≤28 weeks) have inconsistent respiratory drive, airway instability, surfactant deficiency and immature lungs that frequently result in respiratory failure. Managemen...

Eligibility Criteria

Inclusion

  • All infants admitted to the NICU with a birth weight ≤ 1250 grams AND
  • Need for endotracheal tube mechanical ventilation

Exclusion

  • Infants with major congenital anomalies
  • Infants with congenital heart disease and cardiac arrhythmias
  • Infants receiving vasopressor or sedative drugs at the time of extubation
  • Infants extubated directly from high frequency ventilation
  • Infants extubated to room air, oxyhood or low-flow nasal cannula

Key Trial Info

Start Date :

September 1 2013

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 1 2018

Estimated Enrollment :

266 Patients enrolled

Trial Details

Trial ID

NCT01909947

Start Date

September 1 2013

End Date

December 1 2018

Last Update

April 1 2019

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Wayne State University

Detroit, Michigan, United States, 48201

2

Women and Infants Hospital of Rhode Island

Providence, Rhode Island, United States, 02905

3

Royal Victoria Hospital

Montreal, Quebec, Canada, H3A 1A1

4

Montreal Children's Hospital

Montreal, Quebec, Canada, H3H 1P3