Pre-TermNInHeDyNeoNCT04200807
Non-invasive Measurement of Neonatal Central and Peripheral Hemodynamics
An observational study of Pre-Term and Neonatal Infection, run by Vilnius University at 1 site in Lithuania.
Trial summary
Non-invasively neonatal cardiac output can be measured by multiple methods, but the gold standard still remains conventional echocardiography. It is accurate, but needs a long training for new users to assess cardiac function. Read more about this study
- Who is it for?
- Ages 26 to 44 weeksHealthy volunteers can take part
- Conditions the study is for
- Pre-Term, Neonatal Infection
- What is being tested?
- Ultrasound Cardiac Output Monitor (USCOM 1A)
- Type of treatment
- Medical device
- How many people
- 163 participants
- Where
- 1 siteLithuania
- Study dates
- 12 Sep 2017to 30 Sep 2020
- 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 26 to 44 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study enrolled both preterm and full-term newborns of any gestational age, without congenital heart defects and/or hemodynamically significant fetal circulation, any respiratory therapy, nor need of supplemental oxygen. Subjects had no clinically and laboratory-identified infections in control group.
Who may be able to join
- newborns of any gestational age
- parental consent acquired
Who cannot join
- congenital malformations
- hemodynamic instability in control group
- any respiratory support in control group
- infection in control group
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Measurement of Neonatal Central and Peripheral Hemodynamics, as Valuable Diagnostic and Treatment Efficiency Criterium of Neonatal Sepsis
Non-invasively neonatal cardiac output can be measured by multiple methods, but the gold standard still remains conventional echocardiography. It is accurate, but needs a long training for new users to assess cardiac function. Continuous-wave Doppler ultrasound monitor USCOM is a relatively new monitor which can perform faster and less complex cardiac function measurement, also it is easier for the operator to get trained. The aim of the study is to assess the level of agreement between cardiac output measured with conventional echocardiography and with USCOM, to present normal ranges for neonates of different gestational age and to look for early signs of hemodynamic changes during sepsis.
- Conditions
- Pre-Term, Neonatal Infection
- Being tested
- Ultrasound Cardiac Output Monitor (USCOM 1A)
- Keywords
- cardiac output; echocardiography; USCOM; neonates
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Cardiac Output Monitor (USCOM 1A)Device
Also called GE LOGIQ S8 XDclear 2.0 ultrasound system with S4-10-D (3-9MHz) probe, NONIN Equanox near-infrared spectroscope
doplerometry with USCOM and echocardiograph is made for assessing central blood flow and spectroscopy with NONIN- for the blood flow in individual peripheral organs (brain and kidney)
| Study group | Role | What they receive |
|---|---|---|
| Healthy preterm neonate | Neonate 26 weeks to 36 weeks + 6 days of gestation, without congenital heart defects and/or hemodynamically significant fetal circulation, any respiratory therapy, nor need of supplemental oxygen. Subjects had no clinically and laboratory-identified infections. Receives: Device: Ultrasound Cardiac Output Monitor (USCOM 1A) | |
| Healthy term neonate | Neonate from 37 weeks of gestation, without congenital heart defects and/or hemodynamically significant fetal circulation, any respiratory therapy, nor need of supplemental oxygen. Subjects had no clinically and laboratory-identified infections. Receives: Device: Ultrasound Cardiac Output Monitor (USCOM 1A) | |
| Sick neonate | Neonate of any gestation, without congenital heart defects, with clinically and laboratory-identified infection. Receives: Device: Ultrasound Cardiac Output Monitor (USCOM 1A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight measurement
weight in grams
Measured: 1 minute
Height measurement
length in centimeters
Measured: 1 minute
Chest and head circumference
Chest and head circumference in centimeters
Measured: 1 minute
Blood pressure measurement
non- invasive arterial blood pressure measurement in mmHg
Measured: 1 minute
Pulse rate measurement
pulse rate in beats per minute
Measured: 1 minute
Near- Infrared Spectroscopy for regional blood flow
One sensor on the forehead, another- on the back to check for regional blood flow in the brain and kidney with Near- Infrared Spectroscopy
Measured: 15-20 minutes
Echocardioscopy for left ventricular outflow tract diameter
Echocardiography for left ventricular outflow tract diameter in centimeters
Measured: 2-3 minutes
Echocardioscopy to measure velocity time integral
Echocardiography to measure velocity time integral at the aortic valve in centimeters. After that the software of the device calculates cardiac output.
Measured: 3 minutes
USCOM examination
USCOM 1A uses continuous wave Doppler for flow curves, which are obtained at the suprasternal notch for an optimal flow signal at the aortic valve. The software of the device calculates cardiac output then
Measured: 3-5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start12 Sep 2017
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
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 Pre-TermStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vytautas Usonis, MD, Study director, Vilnius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04200807
- Sponsor's protocol ID
- NCPKV-2017
- Acronym
- NInHeDyNeo
- Status last verified
- Sep 2020
- First submitted
- 18 Nov 2019
- Last updated
- 21 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pliauckiene A, Liubsys A, Vankeviciene R, Usonis V. Ultrasonic cardiac output monitor provides effective non-invasive bedside measurements of neonatal cardiac output. J Clin Monit Comput. 2022 Jun;36(3):803-807. doi: 10.1007/s10877-021-00711-2. Epub 2021 Apr 30.
PubMed 33929641
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Measurement of Neonatal Central and Peripheral Hemodynamics, as Valuable Diagnostic and Treatment Efficiency Criterium of Neonatal Sepsis
- ClinicalTrials.gov ID
- NCT04200807
- Acronym / sponsor ID
- NInHeDyNeo / NCPKV-2017
- Conditions
- Pre-Term, Neonatal Infection
- Keywords
- cardiac output; echocardiography; USCOM; neonates
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 16 Dec 2019 (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.
Non-invasively neonatal cardiac output can be measured by multiple methods, but the gold standard still remains conventional echocardiography. It is accurate, but needs a long training for new users to assess cardiac function. Continuous-wave Doppler ultrasound monitor USCOM is a relatively new monitor which can perform faster and less complex cardiac function measurement, also it is easier for the operator to get trained. The aim of the study is to assess the level of agreement between cardiac output measured with conventional echocardiography and with USCOM, to present normal ranges for neonates of different gestational age and to look for early signs of hemodynamic changes during sepsis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy preterm neonate | – | Device: Ultrasound Cardiac Output Monitor (USCOM 1A)Neonate 26 weeks to 36 weeks + 6 days of gestation, without congenital heart defects and/or hemodynamically significant fetal circulation, any respiratory therapy, nor need of supplemental oxygen. Subjects had no clinically and laboratory-identified infections. |
| Healthy term neonate | – | Device: Ultrasound Cardiac Output Monitor (USCOM 1A)Neonate from 37 weeks of gestation, without congenital heart defects and/or hemodynamically significant fetal circulation, any respiratory therapy, nor need of supplemental oxygen. Subjects had no clinically and laboratory-identified infections. |
| Sick neonate | – | Device: Ultrasound Cardiac Output Monitor (USCOM 1A)Neonate of any gestation, without congenital heart defects, with clinically and laboratory-identified infection. |
Who may qualify
- Ages
- 26 to 44 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study enrolled both preterm and full-term newborns of any gestational age, without congenital heart defects and/or hemodynamically significant fetal circulation, any respiratory therapy, nor need of supplemental oxygen. Subjects had no clinically and laboratory-identified infections in control group.
Key inclusion criteria (2 listed)
- newborns of any gestational age
- parental consent acquired
Key exclusion criteria (4 listed)
- congenital malformations
- hemodynamic instability in control group
- any respiratory support in control group
- infection in control group
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 |
|---|---|---|
| Ultrasound Cardiac Output Monitor (USCOM 1A)Also: GE LOGIQ S8 XDclear 2.0 ultrasound system with S4-10-D (3-9MHz) probe, NONIN Equanox near-infrared spectroscopedoplerometry with USCOM and echocardiograph is made for assessing central blood flow and spectroscopy with NONIN- for the blood flow in individual peripheral organs (brain and kidney) | Device | Healthy preterm neonate, Healthy term neonate, Sick neonate |
Primary outcome
Weight measurement
Time frame: 1 minute
weight in grams
Height measurement
Time frame: 1 minute
length in centimeters
Chest and head circumference
Time frame: 1 minute
Chest and head circumference in centimeters
Blood pressure measurement
Time frame: 1 minute
non- invasive arterial blood pressure measurement in mmHg
Pulse rate measurement
Time frame: 1 minute
pulse rate in beats per minute
Near- Infrared Spectroscopy for regional blood flow
Time frame: 15-20 minutes
One sensor on the forehead, another- on the back to check for regional blood flow in the brain and kidney with Near- Infrared Spectroscopy
Echocardioscopy for left ventricular outflow tract diameter
Time frame: 2-3 minutes
Echocardiography for left ventricular outflow tract diameter in centimeters
Echocardioscopy to measure velocity time integral
Time frame: 3 minutes
Echocardiography to measure velocity time integral at the aortic valve in centimeters. After that the software of the device calculates cardiac output.
USCOM examination
Time frame: 3-5 minutes
USCOM 1A uses continuous wave Doppler for flow curves, which are obtained at the suprasternal notch for an optimal flow signal at the aortic valve. The software of the device calculates cardiac output then
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 21 Apr 2021.
- Derived from this study: PubMed 33929641Pliauckiene A, Liubsys A, Vankeviciene R, Usonis V. Ultrasonic cardiac output monitor provides effective non-invasive bedside measurements of neonatal cardiac output. J Clin Monit Comput. 2022 Jun;36(3):803-807. doi: 10.1007/s10877-021-00711-2. Epub 2021 Apr 30.
- Individual participant dataSharing planned: Undecided
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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.
Vytautas Usonis, MD study director
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 Pre-Term and Neonatal Infection, 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 2 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 21 Apr 2021. 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?
Weight measurement (time frame: 1 minute). The study lists 9 primary outcomes in all. 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 NCT04200807, 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 21 Apr 2021.