Relationship Between EIT and Respiratory Status in Very Preterm Infants

NCT06609135 | Completed Results FDA Device

• 1 other identifier: STUDY00001180
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Lung Disease of Prematurity; Bronchopulmonary Dysplasia; Premature Lungs

Keywords

Electrical Impedance Tomography (EIT); Prematurity; Pulmonary Function Testing; Noninvasive ventilation; Continuous Positive Airway Pressure (CPAP); Transcutaneous CO2 monitor (TCOM)

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

Study Arms (1)

Electrical Impedance Tomography (EIT) and CO2 monitor

EXPERIMENTAL

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); Device: Sentec Digital Monitoring System (transcutaneous CO2 monitor)

Interventions

Sentec LuMon Device (EIT system) DEVICE

Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge.

Electrical Impedance Tomography (EIT) and CO2 monitor

Sentec Digital Monitoring System (transcutaneous CO2 monitor) DEVICE

Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.

Electrical Impedance Tomography (EIT) and CO2 monitor

Eligibility Criteria

• Age: 5 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Lawrence Rhein: lead
• SenTec AG, Ringstrasse 39, CH-4106 Therwil: collaborator

Study Sites (1)

UMASS Memorial Medical Center

Worcester, Massachusetts, 01605, United States

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Premature Birth

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Limitations and Caveats

Missing data due to enrollment timing, research staff limitations. The primary outcome is missing data in 9 of 20 infants. The secondary outcomes are missing 4 of 14 and 3 of 10 respectively. There is also potential of measurement error/noise due to variations in belt positioning, infant movement, and interference from respiratory monitoring equipment. The small sample size restricted ability to detect significant differences especially in secondary objectives as few infants analyzed.

Results Point of Contact

• Title: Dr. Lawrence Rhein, Chair of Pediatrics at UMASS Chan Medical School
• Organization: UMASS Chan Medical School

lawrence.rhein@umassmemorial.org

5083346581

Study Officials

• Lawrence Rhein, MD, MPH

  UMASS Chan Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chair, Department of Pediatrics

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: September 24, 2024
• Study Start: November 4, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: October 9, 2025
• Results First Posted: October 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The plan is to share all IPD the underlie the results of a publication within 6 months of publication.
• 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.

Locations

US (1)