Relationship Between EIT and Respiratory Status in Very Preterm Infants

September 22, 2025 updated by: Lawrence Rhein

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: 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.
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.
Time Frame: 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.
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.
Time Frame: 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.
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.
Time Frame: 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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Time Frame: 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.
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.
Time Frame: 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.
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.
Time Frame: 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.
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.
Time Frame: 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.
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.
Time Frame: 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.
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.
Time Frame: 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.
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.
Time Frame: 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.
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.
Time Frame: 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.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lawrence Rhein

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
SenTec AG, Ringstrasse 39, CH-4106 Therwil

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lawrence Rhein, MD, MPH, UMass Chan Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 4, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings