Premature InfantNCT03797183
Genesis Electrical Impedance Tomography (EIT): A Preliminary Study
An observational study of Premature Infant and Chronic Respiratory Disease, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the Genesis Electrical Impedance Tomography (EIT) imaging system for use in pediatric respiratory disease populations including neuromuscular and bronchopulmonary dysplasia, as well as in age and height matched controls. Read more about this study
- Who is it for?
- Ages 14 days to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Premature Infant, Chronic Respiratory Disease, Neuromuscular Diseases
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2019to Nov 2026
- 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 14 days to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: pediatric respiratory disease populations including neuromuscular and bronchopulmonary dysplasia, as well as in age and height matched controls. Populations who will be undergoing cardiac catheterization for pulmonary vein stenosis, pulmonary hypertension and/or pulmonary artery stenosis
Who may be able to join
- 2 weeks old - 40 years old
- Premature infants with current age >2 weeks with a confirmed diagnosis of BPD based on NIH criteria
- Or Chronic respiratory disease due to underlying neuromuscular disease
- Or confirmed neuromuscular disease with an echo completed within the preceding 12 months of study participation of DMD or other diagnoses associated with mild cardiomyopathy.
- have had a VQ scan
- will be undergoing cardiac catherization for for pulmonary vein stenosis, pulmonary hypertension and/or pulmonary artery stenosis
- Or healthy controls
Who cannot join
- <2 weeks of age
- Congenital diaphragmatic hernia
- Severe congenital heart disease
- Significant genetic abnoralities
- Anything that interferes with lead placement on the chest wall
- Unwilling/refusal to sign consent
Show all 10Show fewer
- Pregnant or lactating
- Pacemaker of other surgical implant and spinal implant (causes noise in the data)
- Moderate to severe cardiomyopathy
- Patients with temporary cognitive disability due to illness
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
Emily DeBoer, MD, 720-777-4953, emily.deboer@childrenscolorado.org
Allison Keck, 720-777-0734, allison.keck@childrenscolorado.org
About this study
Official title: The Associations Between EIT and Clinical Measures During Standard of Care Procedures in Patients With Respiratory Disease: A Preliminary Study
The purpose of this study is to evaluate the Genesis Electrical Impedance Tomography (EIT) imaging system for use in pediatric respiratory disease populations including neuromuscular and bronchopulmonary dysplasia, as well as in age and height matched controls. The EIT does not use radiation, and is read through electrodes.
Read the detailed description
The purpose of this study is to evaluate EIT for use in pediatric respiratory disease populations including neuromuscular and bronchopulmonary dysplasia, as well as in age and height matched controls.
Researchers will use EIT to determine changes in regional ventilation with pulmonary interventions including airway clearance and invasive and noninvasive ventilation in a pediatric respiratory disease population.
- Conditions
- Premature Infant, Chronic Respiratory Disease, Neuromuscular Diseases, Healthy, Bronchopulmonary Dysplasia, Pulmonary Vein Stenoses
- Medical subject headings
- Premature Birth, Neuromuscular Diseases, Bronchopulmonary Dysplasia, Stenosis, Pulmonary Vein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Premature Infants | Premature infants >1 month of age currently hospitalized with bronchopulmonary dysplasia (BPD) without acute respiratory infection | |
| Chronic Respiratory Disease | Participants ages >1 month-21 years with chronic respiratory disease due to underlying neuromuscular disease | |
| Neuromuscular Disease | Participants ages 21-40 years with confirmed neuromuscular disease with an echo completed within the preceding 12 months of study participation of Duchenne muscular dystrophy (DMD) or other diagnoses associated with mild cardiomyopathy | |
| Healthy Controls | Age and height matched healthy controls | |
| V/Q Scan validation | Adults or children who are having or have recently had a V/Q scan | |
| Premature Infants (Longitudinal Cohort) | Premature infants ages 2 weeks to 1 year with diagnosed or suspected bronchopulmonary dysplasia | |
| Pulmonary Vein/Artery Stenosis | Children age 2 months to 18 years, who will be undergoing cardiac catheterization for pulmonary vein stenosis, pulmonary hypertension and/or pulmonary artery stenosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
EIT imaging maps that provide regional information regarding 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: 24 months
Secondary outcomes (5)
Regional conductivity changes due to ventilation
Describe regional ventilation in pediatric respiratory disease populations including neuromuscular weakness, skeletal/chest wall disorders, and chronic airway and parenchymal lung disease including bronchopulmonary dysplasia.
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.
Measured: 24 months
Waveform for a mesh element
Time-series waveform indicated by time in seconds compared to Recon signal (au).
Measured: 24 months
Regional conductivity changes due to perfusion
This is a qualitative and quantitative aim. 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: 24 months
Regional pulsatile perfusion imaging at the end of systole
Measured: 5 minutes
Power waveform (computed as the inner product of measured voltages and applied currents)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start3 May 2019
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature InfantStudies 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797183
- Sponsor's protocol ID
- 18-1843
- Status last verified
- Nov 2025
- First submitted
- 28 Dec 2018
- Last updated
- 13 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Associations Between EIT and Clinical Measures During Standard of Care Procedures in Patients With Respiratory Disease: A Preliminary Study
- ClinicalTrials.gov ID
- NCT03797183
- Acronym / sponsor ID
- 18-1843
- Conditions
- Premature Infant, Chronic Respiratory Disease, Neuromuscular Diseases, Healthy, Bronchopulmonary Dysplasia, Pulmonary Vein Stenoses
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 3 May 2019 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 9 Jan 2019 (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.
The purpose of this study is to evaluate the Genesis Electrical Impedance Tomography (EIT) imaging system for use in pediatric respiratory disease populations including neuromuscular and bronchopulmonary dysplasia, as well as in age and height matched controls. The EIT does not use radiation, and is read through electrodes.
Detailed description
The purpose of this study is to evaluate EIT for use in pediatric respiratory disease populations including neuromuscular and bronchopulmonary dysplasia, as well as in age and height matched controls.
Researchers will use EIT to determine changes in regional ventilation with pulmonary interventions including airway clearance and invasive and noninvasive ventilation in a pediatric respiratory disease population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Premature Infants | – | –Premature infants >1 month of age currently hospitalized with bronchopulmonary dysplasia (BPD) without acute respiratory infection |
| Chronic Respiratory Disease | – | –Participants ages >1 month-21 years with chronic respiratory disease due to underlying neuromuscular disease |
| Neuromuscular Disease | – | –Participants ages 21-40 years with confirmed neuromuscular disease with an echo completed within the preceding 12 months of study participation of Duchenne muscular dystrophy (DMD) or other diagnoses associated with mild cardiomyopathy |
| Healthy Controls | – | –Age and height matched healthy controls |
| V/Q Scan validation | – | –Adults or children who are having or have recently had a V/Q scan |
| Premature Infants (Longitudinal Cohort) | – | –Premature infants ages 2 weeks to 1 year with diagnosed or suspected bronchopulmonary dysplasia |
| Pulmonary Vein/Artery Stenosis | – | –Children age 2 months to 18 years, who will be undergoing cardiac catheterization for pulmonary vein stenosis, pulmonary hypertension and/or pulmonary artery stenosis |
Who may qualify
- Ages
- 14 days to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- pediatric respiratory disease populations including neuromuscular and bronchopulmonary dysplasia, as well as in age and height matched controls. Populations who will be undergoing cardiac catheterization for pulmonary vein stenosis, pulmonary hypertension and/or pulmonary artery stenosis
Key inclusion criteria (7 listed)
- 2 weeks old - 40 years old
- Premature infants with current age >2 weeks with a confirmed diagnosis of BPD based on NIH criteria
- Or Chronic respiratory disease due to underlying neuromuscular disease
- Or confirmed neuromuscular disease with an echo completed within the preceding 12 months of study participation of DMD or other diagnoses associated with mild cardiomyopathy.
- have had a VQ scan
Key exclusion criteria (10 listed)
- <2 weeks of age
- Congenital diaphragmatic hernia
- Severe congenital heart disease
- Significant genetic abnoralities
- Anything that interferes with lead placement on the chest wall
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
EIT imaging maps that provide regional information regarding ventilation and perfusion of the lung.
Time frame: 24 months
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.
5 secondary outcomes
Regional conductivity changes due to ventilation
Time frame: 24 months
Waveform for a mesh element
Time frame: 24 months
Regional conductivity changes due to perfusion
Time frame: 24 months
Regional pulsatile perfusion imaging at the end of systole
Time frame: 5 minutes
Power waveform (computed as the inner product of measured voltages and applied currents)
Time frame: 24 months
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 13 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Premature Infant
Recruiting
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
Very Preterm Infant, Necrotizing Enterocolitis (NEC)
Recruiting
Nutritional Maturity in Preterm Newborns (Premature Infant Oral Motor Intervention, PIOMI)
Preterm, Preterm Infant Development
RecruitingPhase 4
Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
Extreme Prematurity,Extremely Low Birthweight, BPD - Bronchopulmonary Dysplasia
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
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.
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 Premature Infant and Chronic Respiratory Disease, 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 7 inclusion and 10 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 13 Nov 2025. 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 Emily DeBoer, MD (720-777-4953, emily.deboer@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 regional information regarding ventilation and perfusion of the lung. (time frame: 24 months). 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 13 Nov 2025.