Evaluating a new imaging system for pediatric respiratory diseases
The Associations Between EIT and Clinical Measures During Standard of Care Procedures in Patients With Respiratory Disease: A Preliminary Study
This study is testing a new imaging system to see if it can help monitor breathing in children with respiratory diseases and compare it to healthy kids.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 14 Days to 40 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT03797183 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the Genesis Electrical Impedance Tomography (EIT) imaging system in pediatric populations suffering from respiratory diseases, including bronchopulmonary dysplasia and neuromuscular conditions. The EIT technology is non-invasive and utilizes electrodes to monitor changes in regional ventilation during various pulmonary interventions. Participants will include both affected children and healthy controls matched by age and height, allowing for a comprehensive evaluation of the system's effectiveness in real-time monitoring of respiratory function.
Who should consider this trial
Good fit: Ideal candidates include premature infants over 2 weeks old with bronchopulmonary dysplasia, children with chronic respiratory diseases due to neuromuscular conditions, and healthy controls aged 2 weeks to 40 years.
Not a fit: Patients under 2 weeks of age, those with severe congenital heart disease, or significant genetic abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management and treatment of respiratory diseases in children by providing a safer, radiation-free imaging option.
How similar studies have performed: While the use of EIT in pediatric populations is relatively novel, similar imaging techniques have shown promise in other medical fields, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aurora, Colorado
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Emily DeBoer, MD
- Email: emily.deboer@childrenscolorado.org
- Phone: 720-777-4953
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.