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OpenTrials
Completed

NCT Number: NCT04542096

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gestational age <32 weeks OR birthweight <1500 g.
  • Need of respiratory therapy (invasive or non-invasive)
  • Parental consent.

Exclusion criteria

  • patient does not meet all of the above listed inclusion criteria
  • patients with a pacemaker
  • patients with skin damage/abrasions at the EIT device belt area
  • newborns with significant thoracic deformity

Treatment and study plan

Lung electrical impedance tomography monitoring

Device

A belt for recording changes in electrical impedance in the skin will be fastened for the purpose of this study with no other additional procedures

Primary outcomes

  1. To evaluate the lung aeration properties of very low birth weight neonates using different respiratory therapy methods and regimens.

    Time frame: 1 - 5 days.

    Lung aeration and ventilation will be assessed with EIT. Several methods will be used and compared, based on pixel information of lung aeration, and pressure-volume characteristics, regional ventilation distribution and etc.

Secondary outcomes

  1. To evaluate the characteristics of lung aeration during routine nursing care in preterm very low birthweight infants receiving respiratory support.

    Time frame: 1 - 5 days.

    Same as primary outcome.

  2. To compare lung aeration and regional ventilation distribution between two non-invasive respiratory therapies, constant positive pressure and high-flow nasal cannula in very low birthweight neonates.

    Time frame: 1 - 5 days.

    Same as primary outcome

Other outcomes

  1. Predict criteria and preconditions for the successful extubation using electrical impedance tomography

    Time frame: 3 days

    Same as primary outcome

Sponsors and collaborators

Lead sponsor

Vilnius University

Other

Registry information

Official study title

Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of Very Low Birth Weight (<1500 g) Neonates Using Electric Impedance Tomography

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Sep 9, 2020
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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