Post-Extubation Assessment of Clinical Stability in ELBW Infants (PEACE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Extremely Low Birth Weight Infants
• Intervention / Treatment: Device: Oxygen saturation probe; Device: Near infrared spectroscopy sensors; Device: Electrical impedance tomography

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.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Wissam Shalish, MD, PhD; Phone Number: 22341 +1(514) 4124452; Email: wissam.shalish@mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health center
      • Contact: Wissam Shalish, MD, PhD; Phone Number: 22341 514-412-4400; Email: wissam.shalish@mcgill.ca
      • Principal Investigator: Wissam Shalish, MD PhD
      • Sub-Investigator: Guilherme Sant'Anna, MD PhD
      • Sub-Investigator: Robert E Kearney, PhD
    • Montréal, Quebec, Canada, H3T 1C5
      • Centre Hospitalier Universitaire Sainte-Justine
      • Contact: Sophie Tremblay, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

20 extremely low birth weight preterm infants admitted to the neonatal intensive care unit at the Montreal Children's Hospital.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	To evaluate the time frame needed to recruit patients and percentage of eligible infants recruited	168 hours
Consent rate	To evaluate the percentage of eligible infants consented	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.	168 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	96 hours

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborators: St. Justine's Hospital
• Investigators: Principal Investigator: Wissam Shalish, MD, PhD, McGill University Health Center/Montreal Children's hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: September 1, 2023
• First Submitted That Met QC Criteria: September 7, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: apnea; Electrical impedance tomography; Extubation; Near infrared spectroscopy; Reintubation; intermittent hypoxia; Extremely low birth weight infants; Cerebral and splanchnic oxygenation
• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: 2023-8794

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes