Clinical trial NCT04542096: Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: RDS - Infants
RDS of Prematurity
Respiratory Failure
Prematurity
Very Low Birth Weight Infant
Keywords: electrical impedance tomography
Lead sponsor: Vilnius University
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 72
Sex: ALL
Minimum age (years): 22
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All neonates meeting eligibility criteria and treated in the Neonatal Intensive Care Unit will be invited to participate in the study. All subjects will be assessed, diagnosed and treated according to institutional guidelines.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the lung aeration properties of very low birth weight neonates using different respiratory therapy methods and regimens.
timeFrame: 1 - 5 days.
Secondary outcomes:
measure: To evaluate the characteristics of lung aeration during routine nursing care in preterm very low birthweight infants receiving respiratory support.
timeFrame: 1 - 5 days.
measure: 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.
timeFrame: 1 - 5 days.
Other outcomes:
measure: Predict criteria and preconditions for the successful extubation using electrical impedance tomography
timeFrame: 3 days
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius University Santaros Klinikos
Study officials:
affiliation: Vilnius University
name: Arūnas Liubšys, MD
role: PRINCIPAL_INVESTIGATOR
References: