RecruitingNot Applicable

Genesis Electrical Impedance Tomography (EIT): A Preliminary Study

United States90 participantsStarted 2019-05-03

Plain-language 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. The EIT does not use radiation, and is read through electrodes.

Who can participate

Age range

14 Days – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * \<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 * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

EIT imaging maps that provide regional information regarding ventilation and perfusion of the lung.

Timeframe: 24 months

Trial details

NCT IDNCT03797183

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-11

Contact for this trial

Emily DeBoer, MD

720-777-4953 emily.deboer@childrenscolorado.org

View on ClinicalTrials.gov More Premature Infant trials