Trial Outcomes & Findings for Relationship Between EIT and Respiratory Status in Very Preterm Infants (NCT NCT06609135)

Last Updated: 2025-10-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

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.

Results posted on

2025-10-09

Participant Flow

The enrollment period lasted from November 2023 through August 2024. Recruitment occured in the UMASS Memorial Medical Center NICU. 40 very preterm infants were screened, 37 were eligible, 33 were approached, and 20 were successfully enrolled.

Participant milestones

Participant milestones
Measure	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. Sentec LuMon Device (EIT system): Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge. Sentec Digital Monitoring System (transcutaneous CO2 monitor): Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Relationship Between EIT and Respiratory Status in Very Preterm Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Electrical Impedance Tomography (EIT) and CO2 Monitor n=20 Participants 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. Sentec LuMon Device (EIT system): Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge. Sentec Digital Monitoring System (transcutaneous CO2 monitor): Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.
Age, Categorical <=18 years	20 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	0 years STANDARD_DEVIATION 0 • n=93 Participants
Sex: Female, Male Female	12 Participants n=93 Participants
Sex: Female, Male Male	8 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	20 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	20 participants n=93 Participants
Birth Gestational Age	28.2 weeks STANDARD_DEVIATION 1.5 • n=93 Participants
Birth Weight	1124 grams STANDARD_DEVIATION 280 • n=93 Participants
Vaginal Delivery	9 Participants n=93 Participants
Betamethasone complete	14 Participants n=93 Participants
Postnatal Diuretics	3 Participants n=93 Participants
Postnatal Steroids	4 Participants n=93 Participants
Chronic Lung Disease of Prematurity	6 Participants n=93 Participants

PRIMARY outcome

Timeframe: 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.

Population: Data at 31 weeks was available for 3 of the 6 infants that weaned to room air at 32 weeks

Outcome measures

Outcome measures
Measure	Electrical Impedance Tomography (EIT) and CO2 Monitor n=3 Participants 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. Sentec LuMon Device (EIT system): Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge. Sentec Digital Monitoring System (transcutaneous CO2 monitor): Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.
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.	0.54 score on a scale Standard Deviation 0.03

PRIMARY outcome

Population: Data at 31 weeks was available for 8 of 14 infants that did not wean to room air at 32 weeks

Outcome measures

Outcome measures
Measure	Electrical Impedance Tomography (EIT) and CO2 Monitor n=8 Participants 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. Sentec LuMon Device (EIT system): Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge. Sentec Digital Monitoring System (transcutaneous CO2 monitor): Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.
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.	0.7 score on a scale Standard Deviation 0.13

PRIMARY outcome

Population: Data at 31 weeks was available for 3 of the 6 infants that weaned to room air at 32 weeks

Outcome measures

Outcome measures
Measure	Electrical Impedance Tomography (EIT) and CO2 Monitor n=3 Participants 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. Sentec LuMon Device (EIT system): Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge. Sentec Digital Monitoring System (transcutaneous CO2 monitor): Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.
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.	85 percentage of total lung space Standard Deviation 2

PRIMARY outcome

Population: Data at 31 weeks was available for 8 of the 14 infants that did not wean to room air at 32 weeks

Outcome measures

Outcome measures
Measure	Electrical Impedance Tomography (EIT) and CO2 Monitor n=8 Participants 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. Sentec LuMon Device (EIT system): Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge. Sentec Digital Monitoring System (transcutaneous CO2 monitor): Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.
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.	71 percentage of total lung space Standard Deviation 11

SECONDARY outcome

Timeframe: 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.

Population: Data at 32 weeks was available for all 4 infants that weaned to room air at 33 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.

Outcome measures

Outcome measures
Measure	Electrical Impedance Tomography (EIT) and CO2 Monitor n=4 Participants 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. Sentec LuMon Device (EIT system): Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge. Sentec Digital Monitoring System (transcutaneous CO2 monitor): Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.
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.	0.62 score on a scale Standard Deviation 0.1

SECONDARY outcome

Timeframe: 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.

Population: Data at 32 weeks was available for 6 of 10 infants that did not wean to room air at 33 weeks

Outcome measures

Outcome measures
Measure	Electrical Impedance Tomography (EIT) and CO2 Monitor n=6 Participants 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. Sentec LuMon Device (EIT system): Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge. Sentec Digital Monitoring System (transcutaneous CO2 monitor): Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.
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.	0.67 score on a scale Standard Deviation 0.12

SECONDARY outcome

Timeframe: 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.

Population: Data at 34 weeks was available for 3 of the 4 infants that weaned to room air by 36 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.

Outcome measures

Outcome measures
Measure	Electrical Impedance Tomography (EIT) and CO2 Monitor n=3 Participants 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. Sentec LuMon Device (EIT system): Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge. Sentec Digital Monitoring System (transcutaneous CO2 monitor): Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.
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.	0.55 score on a scale Standard Deviation 0.1

SECONDARY outcome

Timeframe: 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.

Population: Data at 34 weeks was available for 4 of the 6 infants that did not wean to room air by 36 weeks

Outcome measures

Outcome measures
Measure	Electrical Impedance Tomography (EIT) and CO2 Monitor n=4 Participants 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. Sentec LuMon Device (EIT system): Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge. Sentec Digital Monitoring System (transcutaneous CO2 monitor): Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.
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.	0.59 score on a scale Standard Deviation 0.09

SECONDARY outcome

Timeframe: 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.

Population: Data at 32 weeks was available for all 4 infants that weaned to room air at 33 weeks.

Outcome measures

Outcome measures
Measure	Electrical Impedance Tomography (EIT) and CO2 Monitor n=4 Participants 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. Sentec LuMon Device (EIT system): Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge. Sentec Digital Monitoring System (transcutaneous CO2 monitor): Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.
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.	79 percentage of total lung space Standard Deviation 8

SECONDARY outcome

Timeframe: 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.

Population: Data at 32 weeks was available for 6 of 10 infants that did not wean to room air at 33 weeks

Outcome measures

Outcome measures
Measure	Electrical Impedance Tomography (EIT) and CO2 Monitor n=6 Participants 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. Sentec LuMon Device (EIT system): Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge. Sentec Digital Monitoring System (transcutaneous CO2 monitor): Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.
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.	74 percentage of total lung space Standard Deviation 10

SECONDARY outcome

Timeframe: 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.

Population: Data at 34 weeks was available for 3 of the 4 infants that weaned to room air by 36 weeks

Outcome measures

Outcome measures
Measure	Electrical Impedance Tomography (EIT) and CO2 Monitor n=3 Participants 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. Sentec LuMon Device (EIT system): Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge. Sentec Digital Monitoring System (transcutaneous CO2 monitor): Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.
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.	85 percentage of total lung space Standard Deviation 8

SECONDARY outcome

Timeframe: 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.

Population: Data at 34 weeks was available for 4 of the 6 infants that did not wean to room air by 36 weeks

Outcome measures

Outcome measures
Measure	Electrical Impedance Tomography (EIT) and CO2 Monitor n=4 Participants 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. Sentec LuMon Device (EIT system): Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge. Sentec Digital Monitoring System (transcutaneous CO2 monitor): Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.
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.	81 percentage of total lung space Standard Deviation 8

Adverse Events

Electrical Impedance Tomography (EIT) and CO2 Monitor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lawrence Rhein, Chair of Pediatrics at UMASS Chan Medical School

UMASS Chan Medical School

Phone: 5083346581

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place