Post-Extubation Assessment of Clinical Stability in ELBW Infants

Extremely Low Birth Weight Infants Clinical Trial

— PEACE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06037083
• Other study ID #: 2023-8794
• Status: Not yet recruiting
• Start date: November 1, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: September 2023
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Wissam Shalish, MD, PhD
• Phone: +1(514) 4124452
• Email: wissam.shalish[@]mcgill.ca
• Is FDA regulated: No
• Study type: Observational

Clinical 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 electrical impedance tomography) from 20 extremely low birth weight infants at high-risk of reintubation.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: October 30, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Birth Weight
• Extremely Low Birth Weight Infants

Intervention

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).
• 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)

Locations

Country	Name	City	State
Canada	McGill University Health Center	Montreal	Quebec
Canada	Centre Hospitalier Universitaire Sainte-Justine	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre	St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	To evaluate the time frame needed to recruit patients and percentage of eligible infants recruited	168 hours
Primary	Consent rate	To evaluate the percentage of eligible infants consented	168 hours
Primary	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	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
Secondary	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
Secondary	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
Secondary	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