Post-Extubation Assessment of Clinical Stability in ELBW Infants
NCT ID: NCT06037083
Last Updated: 2024-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20 participants
OBSERVATIONAL
2024-10-29
2026-01-31
Brief Summary
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Detailed Description
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Secondary aims will be to longitudinally describe peripheral oxygen saturation, cerebral oxygen saturation, splanchnic oxygen saturation and regional lung ventilation in extremely low birth weight infants with or without reintubation during the 7 days post extubation.
The application of this multimodal monitoring approach using both clinical and physiological data during the postextubation period will help by making the assessment of clinical stability more comprehensive, more objective, more accurate, more standardized, and more reflective of important end-organ function. Thus, the proposed multimodal monitoring could lead to more informed decisions about reintubation and more individualized treatment plans during this critical period, hence potentially leading to better outcomes.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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20 extremely low birth weight infants
In addition to the standard care, all participants will be monitored using an extra oxygen saturation probe, two near infrared spectroscopy sensors, and an electrical impedance tomography belt. Data will be continuously collected from extubation to 168 hours postextubation
Oxygen saturation probe
The high-accuracy oxygen saturation signal will be continuously acquired for 168 hours post extubation from a separate pulse oximeter (Radical-7®, Masimo ROOT platform, MasimoCorp, Irvine, LA).
Near infrared spectroscopy sensors
The cerebral and splanchnic regional oxygen saturation signals will be acquired continuously for 168h post extubation using two near infrared spectroscopy sensors (Masimo ROOT platform, MasimoCorp, Irvine, LA), one placed on the forehead for cerebral oxygenation and one on the abdomen (for splanchnic oxygenation).
Electrical impedance tomography
The regional lung ventilation will be measured using Electrical Impedance Tomography (TIMPEL, USA) at three time points:
* From 1 hour pre-extubation to 2 hours post extubation (total 3 hours)
* Between 24 and 48 hours post extubation (total 3 hours)
* Between 72 and 96 hours post extubation (total 3 hours)
Interventions
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Oxygen saturation probe
The high-accuracy oxygen saturation signal will be continuously acquired for 168 hours post extubation from a separate pulse oximeter (Radical-7®, Masimo ROOT platform, MasimoCorp, Irvine, LA).
Near infrared spectroscopy sensors
The cerebral and splanchnic regional oxygen saturation signals will be acquired continuously for 168h post extubation using two near infrared spectroscopy sensors (Masimo ROOT platform, MasimoCorp, Irvine, LA), one placed on the forehead for cerebral oxygenation and one on the abdomen (for splanchnic oxygenation).
Electrical impedance tomography
The regional lung ventilation will be measured using Electrical Impedance Tomography (TIMPEL, USA) at three time points:
* From 1 hour pre-extubation to 2 hours post extubation (total 3 hours)
* Between 24 and 48 hours post extubation (total 3 hours)
* Between 72 and 96 hours post extubation (total 3 hours)
Eligibility Criteria
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Inclusion Criteria
* Received mechanical ventilation within the first 72h of life,
* Undergoing their first planned extubation within the first 6 weeks of life.
Exclusion Criteria
28 Weeks
ALL
No
Sponsors
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St. Justine's Hospital
OTHER
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Responsible Party
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Wissam Shalish
Assistant Professor of Pediatrics, McGill University Neonatologist, Montreal Children's Hospital
Principal Investigators
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Wissam Shalish, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Center/Montreal Children's hospital
Locations
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Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
McGill University Health Center
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Wissam Shalish, MD PhD
Role: backup
Guilherme Sant'Anna, MD PhD
Role: backup
Robert E Kearney, PhD
Role: backup
Other Identifiers
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2023-8794
Identifier Type: -
Identifier Source: org_study_id
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