Neonates and Preterm InfantsNCT07247474
Triple EIT (Electrical Impedance Tomography)
An observational study of Neonates and Preterm Infants and Cardiopulmonary, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 weeks to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Neonates and Preterm Infants, Cardiopulmonary
- What is being tested?
- Electrical impedance tomography (EIT)
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2026to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 weeks to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children's Hospital Colorado
Who may be able to join
- 2 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
Show all 10Show fewer
- 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)
Who cannot join
- <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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Allison Keck, 720-777-0734, allison.keck@childrenscolorado.org
Katelyn Enzer, MD
About this study
Official title: 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.
- Conditions
- Neonates and Preterm Infants, Cardiopulmonary
- Being tested
- Electrical impedance tomography (EIT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical impedance tomography (EIT)Device
Electrical impedance tomography (EIT) is a noninvasive and non-ionizing imaging technique that describes lung ventilation and perfusion
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Electrical impedance tomography (EIT) | |
| Control | matched healthy controls with no cardiopulmonary disease Receives: Device: Electrical impedance tomography (EIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 hours
Secondary outcomes (3)
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
Measured: 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.
Measured: 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.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start30 Jan 2026
- Primary completionNov 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonates and Preterm InfantsStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Colorado State University
- Responsible party
- Sponsor
- Investigators
- Katelyn Enzer, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247474
- Sponsor's protocol ID
- 25-1298
- Status last verified
- Feb 2026
- First submitted
- 11 Nov 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing the Evolution of Neonatal Lung Disease Throughout Infancy and Childhood Using Electrical Impedance Tomography: A Pilot Study
- ClinicalTrials.gov ID
- NCT07247474
- Acronym / sponsor ID
- 25-1298
- Conditions
- Neonates and Preterm Infants, Cardiopulmonary
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Colorado State University
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiopulmonary disease | – | Device: Electrical impedance tomography (EIT)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 |
| Control | – | Device: Electrical impedance tomography (EIT)matched healthy controls with no cardiopulmonary disease |
Who may qualify
- Ages
- 2 weeks to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children's Hospital Colorado
Key inclusion criteria (10 listed)
- 2 weeks to 25 years of age
- evidence of cardiopulmonary disease including, but not limited to:
- OR matched healthy controls (born at term gestation (>36 weeks gestational age) with no cardiopulmonary disease)
Key exclusion criteria (5 listed)
- <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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical impedance tomography (EIT)Electrical impedance tomography (EIT) is a noninvasive and non-ionizing imaging technique that describes lung ventilation and perfusion | Device | Cardiopulmonary disease, Control |
Primary outcome
EIT Imaging Maps that provide information about regional ventilation and perfusion of the lung
Time frame: 4 hours
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.
3 secondary outcomes
Regional Conductivity Due to Ventilation
Time frame: 4 hours
Regional Conductivity Due to Perfusion
Time frame: 4 hours
Comparison of Ventilation and Perfusion Ratio
Time frame: 4 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katelyn Enzer, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonates and Preterm Infants and Cardiopulmonary, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katelyn Enzer, MD (7207779137, allison.keck@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EIT Imaging Maps that provide information about regional ventilation and perfusion of the lung (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.