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Post-Extubation Assessment of Clinical Stability in ELBW Infants

NCT06037083 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2026-03-30

No results posted yet for this study

Summary

This is an observational, proof-of-concept, feasibility study that aims to evaluate the feasibility of a monitoring system that integrates clinical data, high-resolution waveforms from the bedside monitor, regional oxygenation (via cerebral and splanchnic near-infrared spectroscopy), and regional ventilation (via electrical impedance tomography) from 20 extremely low birth weight infants at high-risk of reintubation.

Conditions

  • Extremely Low Birth Weight Infants

Interventions

DEVICE

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).

DEVICE

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).

DEVICE

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)

Sponsors & Collaborators

  • St. Justine's Hospital

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Wissam Shalish, MD, PhD · McGill University Health Center/Montreal Children's hospital

Eligibility

Max Age
28 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-29
Primary Completion
2026-12-31
Completion
2027-04-30

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 NCT06037083 on ClinicalTrials.gov