RDS - InfantsNCT04542096
Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT
An observational study of RDS - Infants and RDS of Prematurity, run by Vilnius University at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 36 weeks
- Conditions the study is for
- RDS - Infants, RDS of Prematurity, Respiratory Failure
- What is being tested?
- Lung electrical impedance tomography monitoring
- Type of treatment
- Medical device
- How many people
- 72 participants
- Where
- 1 siteLithuania
- Study dates
- 29 Sep 2020to 20 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 36 weeks
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Gestational age <32 weeks OR birthweight <1500 g.
- Need of respiratory therapy (invasive or non-invasive)
- Parental consent.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Lithuania1 site
Vilnius University Santaros Klinikos
Vilnius, Vilnius County, 08661
About this study
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
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.
- Conditions
- RDS - Infants, RDS of Prematurity, Respiratory Failure, Prematurity, Very Low Birth Weight Infant
- Being tested
- Lung electrical impedance tomography monitoring
- Keywords
- electrical impedance tomography
- Medical subject headings
- RDS - infants, Respiratory Distress Syndrome In Premature Infants, Respiratory Insufficiency, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung electrical impedance tomography monitoringDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Patients receiving invasive respiratory therapy (intubated) Receives: Device: Lung electrical impedance tomography monitoring | |
| Group2 | Patients receiving non-invasive respiratory therapy. Receives: Device: Lung electrical impedance tomography monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the lung aeration properties of very low birth weight neonates using different respiratory therapy methods and regimens.
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.
Measured: 1 - 5 days.
Secondary outcomes (2)
To evaluate the characteristics of lung aeration during routine nursing care in preterm very low birthweight infants receiving respiratory support.
Same as primary outcome.
Measured: 1 - 5 days.
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.
Same as primary outcome
Measured: 1 - 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start29 Sep 2020
- Primary completion20 Apr 2024
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RDS - InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arunas Liubsys, Vilnius University
- Investigators
- Arūnas Liubšys, MD, Principal investigator, Vilnius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542096
- Sponsor's protocol ID
- EIT-1
- Status last verified
- Nov 2022
- First submitted
- 1 Sep 2020
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Virsilas E, Liubsys A, Janulionis A, Valiulis A. Noninvasive Respiratory Support Effects on Sighs in Preterm Infants by Electrical Impedance Tomography. Indian J Pediatr. 2023 Jul;90(7):665-670. doi: 10.1007/s12098-022-04413-8. Epub 2022 Dec 21.
PubMed 36539568
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04542096
- Acronym / sponsor ID
- EIT-1
- Conditions
- RDS - Infants, RDS of Prematurity, Respiratory Failure, Prematurity, Very Low Birth Weight Infant
- Keywords
- electrical impedance tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 20 Apr 2024 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 9 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1 | – | Device: Lung electrical impedance tomography monitoringPatients receiving invasive respiratory therapy (intubated) |
| Group2 | – | Device: Lung electrical impedance tomography monitoringPatients receiving non-invasive respiratory therapy. |
Who may qualify
- Ages
- 22 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- Gestational age <32 weeks OR birthweight <1500 g.
- Need of respiratory therapy (invasive or non-invasive)
- Parental consent.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung electrical impedance tomography monitoringA belt for recording changes in electrical impedance in the skin will be fastened for the purpose of this study with no other additional procedures | Device | Group1, Group2 |
Primary outcome
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.
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Derived from this study: PubMed 36539568Virsilas E, Liubsys A, Janulionis A, Valiulis A. Noninvasive Respiratory Support Effects on Sighs in Preterm Infants by Electrical Impedance Tomography. Indian J Pediatr. 2023 Jul;90(7):665-670. doi: 10.1007/s12098-022-04413-8. Epub 2022 Dec 21.
- Individual participant dataSharing planned: No
Related trials for RDS - Infants
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Active, not recruiting
Measuring Diaphragm Electrical Activity in Neonates Using a Smaller Inter-electrode Distance
Respiratory Distress Syndrome, Newborn, Infant, Premature
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arūnas Liubšys, MD principal investigator
Vilnius University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of RDS - Infants and RDS of Prematurity, run by Vilnius University at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the lung aeration properties of very low birth weight neonates using different respiratory therapy methods and regimens. (time frame: 1 - 5 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04542096, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.