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Completed

NCT Number: NCT06609135

Relationship Between EIT and Respiratory Status in Very Preterm Infants

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.

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Key information

Conditions

Chronic Lung Disease of Prematurity Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Premature Lungs Respiratory Tract Diseases Urogenital Diseases Ventilator-Induced Lung Injury

Age range

5 day and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMASS Memorial Medical Center

Worcester, Massachusetts, 01605, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sentec LuMon Device (EIT system)

Device

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

Sentec Digital Monitoring System (transcutaneous CO2 monitor)

Device

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

Primary outcomes

  1. 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.

  2. 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. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Lawrence Rhein

Other

Collaborators

  • SenTec AG, Ringstrasse 39, CH-4106 Therwil

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 24, 2024
Registry last updated
Oct 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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