Recruiting

Electrical Impedance Tomography

Sponsor:

University of Colorado, Denver

Code:

NCT03797183

Conditions

Premature Infant

Chronic Respiratory Disease

Neuromuscular Diseases

Healthy

Bronchopulmonary Dysplasia

Eligibility Criteria

Sex: All

Age: 0 - 40

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Premature Infant

Chronic Respiratory Disease

Neuromuscular Diseases

Healthy

Bronchopulmonary Dysplasia

Study ID

NCT03797183

Start date

May 3, 2019

Status verified date

Nov, 2025

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 40

Healthy Volunteers: Accepted

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

Study Design

Enrollment

90 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • EIT imaging maps that provide regional information regarding ventilation and perfusion of the lung. [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Emily DeBoer, MD

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

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Emily DeBoer, MD

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

Allison Keck

720-777-0734allison.keck@childrenscolorado.org

More Information

Sponsor

University of Colorado, Denver

Last update posted

Nov 13, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2025-11-13.