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NCT04542096

Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT

Completed Last updated 28 March 2025
What this trial tests

trial testing Lung electrical impedance tomography monitoring in RDS - Infants in 72 participants. Completed in 20 May 2024.

Timeline
29 September 2020
Primary endpoint
20 April 2024
20 May 2024

Quick facts

Lead sponsorVilnius University
StatusCompleted
Study typeOBSERVATIONAL
Enrollment72
Start date29 September 2020
Primary completion20 April 2024
Estimated completion20 May 2024
Sites1 location across Lithuania

Drugs / interventions tested

Conditions studied

Sponsor

Vilnius University

Who can join

Adults 22 Weeks to 36 Weeks, any sex, with RDS - Infants or RDS of Prematurity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Electric Impedance Tomography (EIT) is a lung monitoring technique based on the injection of small currents and voltage measurements using electrodes on the skin surface generating cross-sectional images representing impedance change in a slice of the thorax. It is a real time, radiation free, non-invasive and portable. Neonatal respiratory distress syndrome (RDS) is a respiratory disorder resulting from immaturity of the lung structure and lack of surfactant. It is one the most common conditions in premature infants. Many of these infants require either invasive or non-invasive respiratory support. The goal of the study is to investigate the dynamic changes in pulmonary aeration during assisted breathing in very low birthweight preterm infants using pulmonary electrical impedance tomography. Currently most widely used methods to assess respiratory lung function are either invasive and/or indirect (ABG, pulse oximetry, transcutaneous pCO2 measurement), lacks temporal resolution (lung ultrasound) or emit ionizing radiation (CT). EIT provides information on regional lung aeration without the aforementioned shortcomings.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Noninvasive Respiratory Support Effects on Sighs in Preterm Infants by Electrical Impedance Tomography.
    Virsilas E, Liubsys A, Janulionis A, Valiulis A. · · 2023 · cited 4× · PMID 36539568 · DOI 10.1007/s12098-022-04413-8
  2. Respiratory Support Effects over Time on Regional Lung Ventilation Assessed by Electrical Impedance Tomography in Premature Infants.
    Virsilas E, Valiulis A, Kubilius R, Peciuliene S, et al · · 2024 · cited 2× · PMID 38541220 · DOI 10.3390/medicina60030494
  3. Short-Term Effects over Time of Endotracheal Suctioning on Very Low Birth Weight Premature Infants with RDS.
    Virsilas E, Valiulis A, Liubsys A. · · 2025 · PMID 40723001 · DOI 10.3390/children12070808

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