Relationship Between EIT and Respiratory Status in Very Preterm Infants

Relationship Between Electrical Impedance Tomography (EIT) Measurements and Parameters of Respiratory Status in Very Preterm Infants: An Observational Cohort Study

Electrical Impedance Tomography (EIT) is a non-invasive imaging technique that can measure lung function in real time. This study will follow premature infants to see if EIT can help predict which infants will be successful in weaning off respiratory support by 32-33 weeks gestational age. If successful, EIT could be used to develop new guidelines for respiratory support in premature infants.

Study Overview

• Status: Completed
• Conditions: Bronchopulmonary Dysplasia; Chronic Lung Disease of Prematurity; Premature Lungs
• Intervention / Treatment: Device: Sentec LuMon Device (EIT system); Device: Sentec Digital Monitoring System (transcutaneous CO2 monitor)

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • UMass Memorial Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Infants admitted to the University of Massachusetts Memorial Medical Center (UMMMC) Neonatal Intensive Care Unit (NICU)
• Born between 25+0- and 29+6-weeks of gestation

Exclusion Criteria:

• Infants with major congenital anomalies
• Infants with severe hemodynamic instability

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electrical Impedance Tomography (EIT) and CO2 monitor; Participating infants will have the EIT belt placed at a minimum of twice per week throughout the NICU stay. A respiratory therapist or physician will place the EIT belt at the end of a feed and remove it at the next feed. A transcutaneous CO2 monitor will be placed concurrently.	Device: Sentec LuMon Device (EIT system); Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge.; Device: Sentec Digital Monitoring System (transcutaneous CO2 monitor); Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EIT Metric Global Inhomogeneity Index at 31 Weeks Post Menstrual Age in Those Successful in Discontinuation of Non-invasive Ventilation at 32 Weeks Post Menstrual Age.	The primary outcome is to determine whether electrical impedance tomography metrics, specifically Global Inhomogeneity Index (GI) and Functional Lung Space, measured at 31 weeks post menstrual age are associated with successful discontinuation of non-invasive ventilation at 32 weeks post menstrual age. GI, a measure of ventilation inhomogeneity, ranges from 0 (completely homogeneous) to 1 (completely inhomogeneous). Lower GI values are interpreted as better.	3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 30+5/7 and 31+2/7 weeks postmenstrual age=up to 1-3 weeks.
EIT Metric Global Inhomogeneity Index at 31 Weeks Post Menstrual Age in Those Unsuccessful in Discontinuation of Non-invasive Ventilation at 32 Weeks Post Menstrual Age.	The primary outcome is to determine whether electrical impedance tomography metrics, specifically Global Inhomogeneity Index (GI) and Functional Lung Space, measured at 31 weeks post menstrual age are associated with successful discontinuation of non-invasive ventilation at 32 weeks post menstrual age. GI, a measure of ventilation inhomogeneity, ranges from 0 (completely homogeneous) to 1 (completely inhomogeneous). Lower GI values are interpreted as better.	3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 30+5/7 and 31+2/7 weeks postmenstrual age=up to 1-3 weeks.
EIT Metric Functional Lung Space at 31 Weeks Post Menstrual Age in Those Successful in Discontinuation of Non-invasive Ventilation at 32 Weeks Post Menstrual Age.	The primary outcome is to determine whether electrical impedance tomography metrics, specifically Global Inhomogeneity Index (GI) and Functional Lung Space, measured at 31 weeks post menstrual age are associated with successful discontinuation of non-invasive ventilation at 32 weeks post menstrual age.	3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 30+5/7 and 31+2/7 weeks postmenstrual age=up to 1-3 weeks.
EIT Metric Functional Lung Space at 31 Weeks Post Menstrual Age in Those Unsuccessful in Discontinuation of Non-invasive Ventilation at 32 Weeks Post Menstrual Age.	The primary outcome is to determine whether electrical impedance tomography metrics, specifically Global Inhomogeneity Index (GI) and Functional Lung Space, measured at 31 weeks post menstrual age are associated with successful discontinuation of non-invasive ventilation at 32 weeks post menstrual age.	3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 30+5/7 and 31+2/7 weeks postmenstrual age=up to 1-3 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EIT Metric Global Inhomogeneity Index at 32 Weeks Post Menstrual Age in Those Successful in Discontinuation of Non-invasive Ventilation at 33 Weeks Post Menstrual Age.	The first secondary outcome is to determine whether electrical impedance tomography metrics, specifically Global Inhomogeneity Index and Functional Lung Space, measured at 32 weeks post menstrual age are associated with successful discontinuation of non-invasive ventilation at 33 weeks post menstrual age. GI, a measure of ventilation inhomogeneity, ranges from 0 (completely homogeneous) to 1 (completely inhomogeneous). Lower GI values are interpreted as better.	3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 31+5/7 and 32+2/7 weeks postmenstrual age=up to 2-4 weeks.
EIT Metric Global Inhomogeneity Index at 32 Weeks Post Menstrual Age in Those Unsuccessful in Discontinuation of Non-invasive Ventilation at 33 Weeks Post Menstrual Age.	The first secondary outcome is to determine whether electrical impedance tomography metrics, specifically Global Inhomogeneity Index and Functional Lung Space, measured at 32 weeks post menstrual age are associated with successful discontinuation of non-invasive ventilation at 33 weeks post menstrual age. GI, a measure of ventilation inhomogeneity, ranges from 0 (completely homogeneous) to 1 (completely inhomogeneous). Lower GI values are interpreted as better.	3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 31+5/7 and 32+2/7 weeks postmenstrual age=up to 2-4 weeks.
EIT Metric Global Inhomogeneity Index at 34 Weeks Post Menstrual Age in Those Successful in Discontinuation of Non-invasive Ventilation at 36 Weeks Post Menstrual Age.	The second secondary outcome is to determine whether electrical impedance tomography metrics, specifically Global Inhomogeneity Index and Functional Lung Space, measured at 34 weeks post menstrual age are associated with successful discontinuation of non-invasive ventilation at 36 weeks post menstrual age. GI, a measure of ventilation inhomogeneity, ranges from 0 (completely homogeneous) to 1 (completely inhomogeneous). Lower GI values are interpreted as better.	3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 33+5/7 and 34+2/7 weeks postmenstrual age=up to 4-6 weeks.
EIT Metric Global Inhomogeneity Index at 34 Weeks Post Menstrual Age in Those Unsuccessful in Discontinuation of Non-invasive Ventilation at 36 Weeks Post Menstrual Age.	The second secondary outcome is to determine whether electrical impedance tomography metrics, specifically Global Inhomogeneity Index and Functional Lung Space, measured at 34 weeks post menstrual age are associated with successful discontinuation of non-invasive ventilation at 36 weeks post menstrual age. GI, a measure of ventilation inhomogeneity, ranges from 0 (completely homogeneous) to 1 (completely inhomogeneous). Lower GI values are interpreted as better.	3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 33+5/7 and 34+2/7 weeks postmenstrual age=up to 4-6 weeks.
EIT Metric Functional Lung Space at 32 Weeks Post Menstrual Age in Those Successful in Discontinuation of Non-invasive Ventilation at 33 Weeks Post Menstrual Age.	The first secondary outcome is to determine whether electrical impedance tomography metrics, specifically Global Inhomogeneity Index and Functional Lung Space, measured at 32 weeks post menstrual age are associated with successful discontinuation of non-invasive ventilation at 33 weeks post menstrual age.	3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 31+5/7 and 32+2/7 weeks postmenstrual age=up to 2-4 weeks.
EIT Metric Functional Lung Space at 32 Weeks Post Menstrual Age in Those Unsuccessful in Discontinuation of Non-invasive Ventilation at 33 Weeks Post Menstrual Age.	The first secondary outcome is to determine whether electrical impedance tomography metrics, specifically Global Inhomogeneity Index and Functional Lung Space, measured at 32 weeks post menstrual age are associated with successful discontinuation of non-invasive ventilation at 33 weeks post menstrual age.	3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 31+5/7 and 32+2/7 weeks postmenstrual age=up to 2-4 weeks.
EIT Metric Functional Lung Space at 34 Weeks Post Menstrual Age in Those Successful in Discontinuation of Non-invasive Ventilation at 36 Weeks Post Menstrual Age.	The second secondary outcome is to determine whether electrical impedance tomography metrics, specifically Global Inhomogeneity Index and Functional Lung Space, measured at 34 weeks post menstrual age are associated with successful discontinuation of non-invasive ventilation at 36 weeks post menstrual age.	3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 33+5/7 and 34+2/7 weeks postmenstrual age=up to 4-6 weeks.
EIT Metric Functional Lung Space at 34 Weeks Post Menstrual Age in Those Unsuccessful in Discontinuation of Non-invasive Ventilation at 36 Weeks Post Menstrual Age.	The second secondary outcome is to determine whether electrical impedance tomography metrics, specifically Global Inhomogeneity Index and Functional Lung Space, measured at 34 weeks post menstrual age are associated with successful discontinuation of non-invasive ventilation at 36 weeks post menstrual age.	3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 33+5/7 and 34+2/7 weeks postmenstrual age=up to 4-6 weeks.

Collaborators and Investigators

• Sponsor: Lawrence Rhein
• Collaborators: SenTec AG, Ringstrasse 39, CH-4106 Therwil
• Investigators: Principal Investigator: Lawrence Rhein, MD, MPH, UMass Chan Medical School

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2023
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): August 31, 2024

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Estimated): October 9, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Prematurity; Continuous Positive Airway Pressure (CPAP); Noninvasive ventilation; Pulmonary Function Testing; Electrical Impedance Tomography (EIT); Transcutaneous CO2 monitor (TCOM)
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Respiratory Tract Diseases; Lung Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Ventilator-Induced Lung Injury; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Premature Birth; Bronchopulmonary Dysplasia
• Other Study ID Numbers: STUDY00001180

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The EIT and TCOM data, study methodology may be valuable for other clinical investigators and thus worth sharing.
• IPD Sharing Time Frame: The plan is to share all IPD the underlie the results of a publication within 6 months of publication.
• IPD Sharing Access Criteria: Requests by other clinical investigators will be reviewed by with Lawrence Rhein or Mohammad Jaber and if deemed reasonable IPD to be shared.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

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