Extremely Low Birth Weight InfantsPEACENCT06037083
Post-Extubation Assessment of Clinical Stability in ELBW Infants
An observational study of Extremely Low Birth Weight Infants, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 28 weeks
- Conditions the study is for
- Extremely Low Birth Weight Infants
- What is being tested?
- Oxygen saturation probe, Near infrared spectroscopy sensors and Electrical impedance tomography
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 2 sitesCanada
- Study dates
- 29 Oct 2024to Apr 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 28 weeks
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Congenital anomalies and congenital heart disorders.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, H3T 1C5
Sophie Tremblay, MD, FRCPC, MSc, 1-514-345-4931 ext. 4500, sophie.tremblay@umontreal.ca
- Recruiting
McGill University Health Center
Montreal, Quebec, H4A 3J1
Wissam Shalish, MD, PhD, 514-412-4400 ext. 22341, wissam.shalish@mcgill.ca
Wissam Shalish, MD PhD
About this study
Official title: Post-Extubation Assessment of Clinical Stability in Extremely Preterm Infants: The PEACE Feasibility Study
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.
Read the detailed description
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.
- Conditions
- Extremely Low Birth Weight Infants
- Being tested
- Oxygen saturation probe, Near infrared spectroscopy sensors, Electrical impedance tomography
- Keywords
- Reintubation, Extubation, Extremely low birth weight infants, Electrical impedance tomography, Cerebral and splanchnic oxygenation, Near infrared spectroscopy, apnea, intermittent hypoxia
- Medical subject headings
- Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen saturation probeDevice
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 sensorsDevice
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 tomographyDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Oxygen saturation probe; Device: Near infrared spectroscopy sensors; Device: Electrical impedance tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
To evaluate the time frame needed to recruit patients and percentage of eligible infants recruited
Measured: 168 hours
Consent rate
To evaluate the percentage of eligible infants consented
Measured: 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.
Measured: 168 hours
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start29 Oct 2024
- Primary completion31 Dec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extremely Low Birth Weight InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- St. Justine's Hospital
- Responsible party
- Principal investigator, Wissam Shalish, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Wissam Shalish, MD, PhD, Principal investigator, McGill University Health Center/Montreal Children's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037083
- Sponsor's protocol ID
- 2023-8794
- Acronym
- PEACE
- Status last verified
- Mar 2026
- First submitted
- 1 Sep 2023
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No