Post-Extubation Assessment of Clinical Stability in ELBW Infants

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Extremely Low Birth Weight Infants

Intervention / Treatment
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* Device: Oxygen saturation probe
* Device: Near infrared spectroscopy sensors
* Device: Electrical impedance tomography


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 28 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 20 extremely low birth weight infants<br>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<br>* 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).<br>Device: Near infrared spectroscopy sensors<br>* 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).<br>Device: Electrical impedance tomography<br>* 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)<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Near infrared spectroscopy, apnea, intermittent hypoxia, Reintubation, Extubation, Extremely low birth weight infants, Electrical impedance tomography, Cerebral and splanchnic oxygenation