NCT03797183 Genesis Electrical Impedance Tomography (EIT): A Preliminary Study
| NCT ID | NCT03797183 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Premature Infant |
| Study Type | OBSERVATIONAL |
| Enrollment | 90 participants |
| Start Date | 2019-05-03 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 90 participants in total. It began in 2019-05-03 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03797183 clinical trial?
This trial is open to participants of all sexes, aged 14 Days or older, up to 40 Years, studying Premature Infant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03797183 currently recruiting?
Yes, NCT03797183 is actively recruiting participants. Contact the research team at emily.deboer@childrenscolorado.org for enrollment information.
Where is the NCT03797183 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT03797183 clinical trial?
NCT03797183 is sponsored by University of Colorado, Denver. The trial plans to enroll 90 participants.