NCT07247474

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
32mo left

Started Jan 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Jan 2026Dec 2028

First Submitted

Initial submission to the registry

November 11, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 25, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 30, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

2.8 years

First QC Date

November 11, 2025

Last Update Submit

February 19, 2026

Conditions

CardiopulmonaryNeonates and Preterm Infants

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Regional Conductivity Due to Ventilation

    4 hours

  • Regional Conductivity Due to Perfusion

    4 hours

  • Comparison of Ventilation and Perfusion Ratio

    4 hours

Study Arms (2)

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)

Control

matched healthy controls with no cardiopulmonary disease

Device: Electrical impedance tomography (EIT)

Interventions

Electrical impedance tomography (EIT)DEVICE

Electrical impedance tomography (EIT) is a noninvasive and non-ionizing imaging technique that describes lung ventilation and perfusion

Cardiopulmonary diseaseControl

Eligibility Criteria

Age2 Weeks - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children's Hospital Colorado

You may qualify if:

  • weeks to 25 years of age
  • 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
  • OR matched healthy controls (born at term gestation (\>36 weeks gestational age) with no cardiopulmonary disease)

You may not qualify if:

  • \<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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Study Officials

  • Katelyn Enzer, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katelyn Enzer, MD

CONTACT

7207779137allison.keck@childrenscolorado.org

Allison Keck, BS

CONTACT

720-777-0734allison.keck@childrenscolorado.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2025

First Posted

November 25, 2025

Study Start

January 30, 2026

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

February 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)