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Non-invasive Measurement of Neonatal Central and Peripheral Hemodynamics

Non-invasive Measurement of Neonatal Central and Peripheral Hemodynamics, as Valuable Diagnostic and Treatment Efficiency Criterium of Neonatal Sepsis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04200807
Acronym
NInHeDyNeo
Enrollment
163
Registered
2019-12-16
Start date
2017-09-12
Completion date
2020-09-30
Last updated
2021-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Infection, Pre-Term

Keywords

cardiac output; echocardiography; USCOM; neonates

Brief 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. 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.

Interventions

DEVICEUltrasound Cardiac Output Monitor (USCOM 1A)

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)

Sponsors

Vilnius University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
26 Weeks to 44 Weeks
Healthy volunteers
Yes

Inclusion criteria

* newborns of any gestational age * parental consent acquired

Exclusion criteria

* congenital malformations * hemodynamic instability in control group * any respiratory support in control group * infection in control group

Design outcomes

Primary

MeasureTime frameDescription
Weight measurement1 minuteweight in grams
Height measurement1 minutelength in centimeters
Chest and head circumference1 minuteChest and head circumference in centimeters
Blood pressure measurement1 minutenon- invasive arterial blood pressure measurement in mmHg
Pulse rate measurement1 minutepulse rate in beats per minute
Near- Infrared Spectroscopy for regional blood flow15-20 minutesOne 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 diameter2-3 minutesEchocardiography for left ventricular outflow tract diameter in centimeters
Echocardioscopy to measure velocity time integral3 minutesEchocardiography to measure velocity time integral at the aortic valve in centimeters. After that the software of the device calculates cardiac output.
USCOM examination3-5 minutesUSCOM 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

Countries

Lithuania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026