An observational study in Extremely Low Birth Weight Infants, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Recruiting at 2 sites in Canada. Open to participants aged Up to 28 Weeks. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Observational
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.
The primary aim of this proof-of-concept study is to evaluate the feasibility and acceptance of a monitoring system that integrates clinical data and biomedical signals from multiple modalities in a cohort of extremely preterm infants at high-risk of clinical instability on non-invasive respiratory support.
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.
282 studies on the registry are indexed under Apnea; 54 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 78 observational studies indexed under Apnea.
Browse Apnea studies →McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 421 studies on the registry; 105 are open to participants now.
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20 extremely low birth weight preterm infants admitted to the neonatal intensive care unit at the Montreal Children's Hospital and Centre Hospitalier Universitaire Sainte-Justine.
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Exclusion Criteria:
- Congenital anomalies and congenital heart disorders.
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
Device: Oxygen saturation probe · Device: Near infrared spectroscopy sensors · Device: Electrical impedance tomography
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).
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).
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)
Recruitment rate
To evaluate the time frame needed to recruit patients and percentage of eligible infants recruited
Time frame: 168 hours
Consent rate
To evaluate the percentage of eligible infants consented
Time frame: 168 hours
Acceptability of the multimodal monitoring approach
Acceptability of the multimodal monitoring approach will be evaluated using short anonymous surveys distributed to parents, bedside nurses, and attending clinicians participating in the study.
Time frame: 168 hours
To describe longitudinal peripheral blood oxygen saturation patterns for infants with and without reintubation during the 7 days post-extubation
The variable will be longitudinally described and graphically displayed using mean (standard deviation), median (interquartile range), or number (percentage) for the hour pre-extubation and for each 24-hour bin post-extubation, and compared between infants requiring reintubation and those not requiring reintubation during the 7 days after extubation.
Time frame: 168 hours
To describe longitudinal cerebral oxygen saturation patterns for infants with and without reintubation during the 7 days post-extubation
The variable will be longitudinally described and graphically displayed using mean (standard deviation), median (interquartile range), or number (percentage) for the hour pre-extubation and for each 24-hour bin post-extubation, and compared between infants requiring reintubation and those not requiring reintubation during the 7 days after extubation.
Time frame: 168 hours
To describe longitudinal splanchnic oxygen saturation patterns for infants with and without reintubation during the 7 days post-extubation
The variable will be longitudinally described and graphically displayed using mean (standard deviation), median (interquartile range), or number (percentage) for the hour pre-extubation and for each 24-hour bin post-extubation. Repeated measures one-way ANOVA or Friedman test will be used to evaluate for differences in the variables over time.
Time frame: 168 hours
To describe regional lung ventilation from the immediate pre-extubation period until 72-96 hours post-extubation.
The variable will be longitudinally described and graphically displayed using mean (standard deviation), median (interquartile range), or number (percentage) for the hour pre-extubation and for each 24-hour bin post-extubation. Repeated measures one-way ANOVA or Friedman test will be used to evaluate for differences in the variables over time.
Time frame: 96 hours
Plan to share: No
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