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Recruiting NCT07247474

Triple EIT (Electrical Impedance Tomography)

Observational Neonates and Preterm Infants Cardiopulmonary

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electrical impedance tomography (EIT).
Who it may be relevant to
Registry conditions: Neonates and Preterm Infants, Cardiopulmonary. Basic parameters: 2 Weeks — 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

This study plans to learn more about ways to look at participant's lungs using new machines called Electrical Impedance Tomography (EIT). The EIT does not use harmful radiation like CT or x-ray. It is read through electrodes like using EKG reading heartbeats. The investigators want to compare the results of patients who have chronic respiratory disease to patients without chronic respiratory disease to learn more about lung structure and composition.

Interventions

  • Device Electrical impedance tomography (EIT)
    Electrical impedance tomography (EIT) is a noninvasive and non-ionizing imaging technique that describes lung ventilation and perfusion

Primary outcome measures

  • EIT Imaging Maps that provide information about regional ventilation and perfusion of the lung [Time frame: 4 hours]
Secondary outcome measures (3)
  • Regional Conductivity Due to Ventilation [Time frame: 4 hours]
  • Regional Conductivity Due to Perfusion [Time frame: 4 hours]
  • Comparison of Ventilation and Perfusion Ratio [Time frame: 4 hours]

Eligibility criteria

Inclusion criteria

  • 2 weeks to 25 years of age
  • evidence of cardiopulmonary disease including, but not limited to:
  • Post-prematurity respiratory disease
  • Congenital diaphragmatic hernia
  • Pulmonary Hypertension
  • Congenital heart disease
  • Respiratory failure
  • Neuromuscular Disease
  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Children's Hospital Colorado — Aurora

Identifiers

NCT: NCT07247474 · 25-1298

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗