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Completed

NCT Number: NCT04200807

Non-invasive Measurement of Neonatal Central and Peripheral Hemodynamics

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.

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Key information

Conditions

Pre-Term Female Urogenital Diseases and Pregnancy Complications Neonatal Infection Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

26 week–44 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Vilnius University, Neonatology Centre

Vilnius, 08464, Lithuania

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Ultrasound Cardiac Output Monitor (USCOM 1A)

Device

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)

Other names: GE LOGIQ S8 XDclear 2.0 ultrasound system with S4-10-D (3-9MHz) probe, NONIN Equanox near-infrared spectroscope

Primary outcomes

  1. Weight measurement

    Time frame: 1 minute

    weight in grams

  2. Height measurement

    Time frame: 1 minute

    length in centimeters

  3. Chest and head circumference

    Time frame: 1 minute

    Chest and head circumference in centimeters

  4. Blood pressure measurement

    Time frame: 1 minute

    non- invasive arterial blood pressure measurement in mmHg

  5. Pulse rate measurement

    Time frame: 1 minute

    pulse rate in beats per minute

  6. 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

  7. Echocardioscopy for left ventricular outflow tract diameter

    Time frame: 2-3 minutes

    Echocardiography for left ventricular outflow tract diameter in centimeters

  8. 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.

  9. 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

Sponsors and collaborators

Lead sponsor

Vilnius University

Other

Registry information

Official study title

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

Acronym: NInHeDyNeo

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 16, 2019
Registry last updated
Apr 21, 2021

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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