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RECRUITING
NCT06037083

Post-Extubation Assessment of Clinical Stability in ELBW Infants

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

View on ClinicalTrials.gov

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.

Official title: Post-Extubation Assessment of Clinical Stability in Extremely Preterm Infants: The PEACE Feasibility Study

Key Details

Gender

All

Age Range

Any - 28 Weeks

Study Type

OBSERVATIONAL

Enrollment

20

Start Date

2024-10-29

Completion Date

2027-04

Last Updated

2026-03-30

Healthy Volunteers

No

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)

Locations (2)

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, Canada

McGill University Health Center

Montreal, Quebec, Canada