Recruiting

Observational Study

Sponsor:

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

Code:

NCT06037083

Conditions

Extremely Low Birth Weight Infants

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Oxygen saturation probe

Near infrared spectroscopy sensors

Electrical impedance tomography

Study Details

Brief 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

Study ID

NCT06037083

Start date

Oct 29, 2024

Status verified date

Mar, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Birth weight < 1000g and gestational age < 28+0 weeks,
  • Received mechanical ventilation within the first 72h of life,
  • Undergoing their first planned extubation within the first 6 weeks of life.

Exclusion Criteria:

\- Congenital anomalies and congenital heart disorders.

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

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)

Primary outcome measure

  • Recruitment rate [ Time Frame: 168 hours ]
  • Consent rate [ Time Frame: 168 hours ]
  • Acceptability of the multimodal monitoring approach [ Time Frame: 168 hours ]

Central Contacts and Locations

Central contacts

Wissam Shalish, MD, PhD

+1(514) 4124452wissam.shalish@mcgill.ca

Locations

Centre Hospitalier Universitaire Sainte-Justine

Recruiting

Montreal, Quebec, Canada, H3T 1C5

Contacts

Sophie Tremblay, MD, FRCPC, MSc

1-514-345-4931sophie.tremblay@umontreal.ca

McGill University Health Center

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Wissam Shalish, MD, PhD

514-412-4400wissam.shalish@mcgill.ca

Principal Investigator:

Wissam Shalish, MD PhD

More Information

Sponsor

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

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Keywords

  • Reintubation
  • Extubation
  • Extremely low birth weight infants
  • Electrical impedance tomography
  • Cerebral and splanchnic oxygenation
  • Near infrared spectroscopy
  • apnea
  • intermittent hypoxia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2026-03-30.