Triple Electrical Impedance Tomography (EIT) lung imaging in neonates, children, and young adults

Characterizing the Evolution of Neonatal Lung Disease Throughout Infancy and Childhood Using Electrical Impedance Tomography: A Pilot Study

This study will try using electrical impedance tomography (EIT) to compare lung images of infants, children, and young adults with cardiopulmonary disease to those without lung disease.

Quick facts

• Study type: Observational
• Enrollment: 140 (estimated)
• Ages: 2 Weeks to 25 Years
• Sex: All
• Sponsor: University of Colorado, Denver (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Aurora, Colorado)
• Trial ID: NCT07247474 on ClinicalTrials.gov

What this trial studies

This observational study uses non‑ionizing electrical impedance tomography (EIT) to image lung structure and ventilation via chest electrodes, similar to how an EKG reads the heart. Participants aged 2 weeks to 25 years will include those with a range of cardiopulmonary conditions (for example post-prematurity respiratory disease, congenital diaphragmatic hernia, pulmonary hypertension, congenital heart disease, respiratory failure, neuromuscular disease, or developmental lung disorders) and matched healthy term-born controls. Investigators will compare EIT measurements between the disease and control groups to characterize lung composition and ventilation patterns without using CT or X‑ray. Participants with contraindications to electrode placement, pacemakers or other intrathoracic metal implants, pregnancy, or inability to give informed consent will be excluded.

Who should consider this trial

Good fit: Ideal candidates are people aged 2 weeks to 25 years who either have cardiopulmonary disease as listed in the eligibility criteria or are healthy term-born controls with no cardiopulmonary disease.

Not a fit: Patients younger than 2 weeks, those who cannot have electrodes placed on the chest (for example due to skin problems, large dressings, or multiple chest tubes), people with intrathoracic metal implants like pacemakers, pregnant or lactating patients, and those who do not provide informed consent would not benefit from participation.

Why it matters

Potential benefit: If successful, this approach could provide a safer, bedside way to better understand and monitor lung structure and function in infants and children without exposure to radiation.

How similar studies have performed: EIT has been used successfully in other neonatal and adult respiratory studies to monitor ventilation distribution, but methods are still being refined and it is not yet standard clinical practice everywhere.

Eligibility criteria

Inclusion Criteria:

* 2 weeks to 25 years of age
* evidence of cardiopulmonary disease including, but not limited to:

  1. Post-prematurity respiratory disease
  2. Congenital diaphragmatic hernia
  3. Pulmonary Hypertension
  4. Congenital heart disease
  5. Respiratory failure
  6. Neuromuscular Disease
  7. Developmental or congenital lung disease

OR matched healthy controls (born at term gestation (\>36 weeks gestational age) with no cardiopulmonary disease)

Exclusion Criteria:

* \<2 weeks of age
* Anything that interferes with lead placement on the chest wall (such as, dermatologic conditions, multiple chest tubes, anatomic abnormality, or large dressings that cannot be moved)
* No informed consent
* Pregnant or lactating
* Pacemaker or other metal intrathoracic surgical implant (causes noise in the data)

Where this trial is running

Aurora, Colorado

• Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)

Study contacts

• Principal investigator: Katelyn Enzer, MD — University of Colorado, Denver
• Study coordinator: Katelyn Enzer, MD

Conditions Neonates and Preterm Infants; Cardiopulmonary