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Clinical Trials/NCT04200807
NCT04200807
Completed
Not Applicable

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

Vilnius University1 site in 1 country163 target enrollmentSeptember 12, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pre-Term
Sponsor
Vilnius University
Enrollment
163
Locations
1
Primary Endpoint
Weight measurement
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 12, 2017
End Date
September 30, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Weight measurement

Time Frame: 1 minute

weight in grams

Height measurement

Time Frame: 1 minute

length 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.

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

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

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

Echocardioscopy for left ventricular outflow tract diameter

Time Frame: 2-3 minutes

Echocardiography for left ventricular outflow tract diameter in centimeters

Study Sites (1)

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