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NCT Number: NCT06037083

Post-Extubation Assessment of Clinical Stability in ELBW Infants

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.

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Key information

Conditions

Extremely Low Birth Weight Infants Apnea Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

Up to 28 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxygen saturation probe

Device

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

Device

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

Device

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 outcomes

  1. Recruitment rate

    Time frame: 168 hours

    To evaluate the time frame needed to recruit patients and percentage of eligible infants recruited

  2. Consent rate

    Time frame: 168 hours

    To evaluate the percentage of eligible infants consented

  3. Acceptability of the multimodal monitoring approach

    Time frame: 168 hours

    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.

Secondary outcomes

  1. To describe longitudinal peripheral blood oxygen saturation patterns for infants with and without reintubation during the 7 days post-extubation

    Time frame: 168 hours

    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.

  2. To describe longitudinal cerebral oxygen saturation patterns for infants with and without reintubation during the 7 days post-extubation

    Time frame: 168 hours

    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.

  3. To describe longitudinal splanchnic oxygen saturation patterns for infants with and without reintubation during the 7 days post-extubation

    Time frame: 168 hours

    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.

  4. To describe regional lung ventilation from the immediate pre-extubation period until 72-96 hours post-extubation.

    Time frame: 96 hours

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Wissam Shalish, MD, PhD

CONTACT

[email protected]

+1(514) 4124452 ext. 22341

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • St. Justine's Hospital

Registry information

Official study title

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

Acronym: PEACE

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 14, 2023
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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