Triple EIT (Electrical Impedance Tomography)

Characterizing the Evolution of Neonatal Lung Disease Throughout Infancy and Childhood Using Electrical Impedance Tomography: A Pilot Study

This study plans to learn more about ways to look at participant's lungs using new machines called Electrical Impedance Tomography (EIT). The EIT does not use harmful radiation like CT or x-ray. It is read through electrodes like using EKG reading heartbeats.

The investigators want to compare the results of patients who have chronic respiratory disease to patients without chronic respiratory disease to learn more about lung structure and composition.

Study Overview

• Status: Recruiting
• Conditions: Neonates and Preterm Infants; Cardiopulmonary
• Intervention / Treatment: Device: Electrical impedance tomography (EIT)

• Study Type: Observational
• Enrollment (Estimated): 140

Contacts and Locations

• Study Contact: Name: Allison Keck, BS; Phone Number: 720-777-0734; Email: allison.keck@childrenscolorado.org
• Study Contact Backup: Name: Katelyn Enzer, MD; Phone Number: 7207779137; Email: allison.keck@childrenscolorado.org

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Children's Hospital Colorado
      • Contact: Allison Keck; Phone Number: 720-777-0734; Email: allison.keck@childrenscolorado.org
      • Principal Investigator: Katelyn Enzer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Children's Hospital Colorado

Description

Inclusion Criteria:

• 2 weeks to 25 years of age

• evidence of cardiopulmonary disease including, but not limited to:

  1. Post-prematurity respiratory disease
  2. Congenital diaphragmatic hernia
  3. Pulmonary Hypertension
  4. Congenital heart disease
  5. Respiratory failure
  6. Neuromuscular Disease
  7. Developmental or congenital lung disease

OR matched healthy controls (born at term gestation (>36 weeks gestational age) with no cardiopulmonary disease)

Exclusion Criteria:

• <2 weeks of age
• Anything that interferes with lead placement on the chest wall (such as, dermatologic conditions, multiple chest tubes, anatomic abnormality, or large dressings that cannot be moved)
• No informed consent
• Pregnant or lactating
• Pacemaker or other metal intrathoracic surgical implant (causes noise in the data)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cardiopulmonary disease; Have evidence of cardiopulmonary disease including, but not limited to: Post-prematurity respiratory disease; Congenital diaphragmatic hernia; Pulmonary hypertension; Congenital heart disease; Respiratory failure; Neuromuscular disease; Developmental or congenital lung disease May be imaged with two machines	Device: Electrical impedance tomography (EIT); Electrical impedance tomography (EIT) is a noninvasive and non-ionizing imaging technique that describes lung ventilation and perfusion
Control; matched healthy controls with no cardiopulmonary disease	Device: Electrical impedance tomography (EIT); Electrical impedance tomography (EIT) is a noninvasive and non-ionizing imaging technique that describes lung ventilation and perfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EIT Imaging Maps that provide information about regional ventilation and perfusion of the lung	These images will be analyzed both visually for qualitative abnormalities and through quantitative pixel analysis that can provide information regarding lung volume, blood volume, and changes in either based on respiratory cycle, cardiac cycle, or intervention. Areas of low ventilation (atelectasis and consolidation) will be identified.	4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Regional Conductivity Due to Ventilation	This is a qualitative aim and will summarize EIT images pictorially. Pixel densities will be evaluated for normality and summarized as mean (SD) or median (interquartile range). EIT images will be qualitatively compared between cases and controls. Outcome metrics may be generated to measure things such as ventilation heterogeneity	4 hours
Regional Conductivity Due to Perfusion	This is a qualitative and quantitative aim that will only be performed using the ACT5 EIT system. Results will qualitatively compare EIT images with CXR and CT scan images when available. Images will be displayed side by side and interpreted by both the clinician and the EIT study staff. Various summary measures of EIT outcomes will be calculated including pixel heterogeneity, summary changes over tidal breath and variation between tidal peaks. Pearson and Spearman correlation will be calculated between summary EIT outcomes and continuous primary clinical values. Linear and logistic regression will be used to estimate associations (with 95% CI) between EIT measures and clinical outcomes. Summary data will be presented in tables and figures using basic descriptive statistics stratified by study group.	4 hours
Comparison of Ventilation and Perfusion Ratio	In participants with both ventilation and perfusion metrics from the ACT5 EIT system, a regional comparison of ventilation and perfusion will be generated. These values will indicate whether a segment of the lung has relatively more or less ventilation or perfusion.	4 hours

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Colorado State University
• Investigators: Principal Investigator: Katelyn Enzer, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: November 11, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 25-1298

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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