Non-invasive Measurement of Neonatal Central and Peripheral Hemodynamics

Study Overview
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Brief Summary
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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.

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

Conditions
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Pre-Term, Neonatal Infection

Intervention / Treatment
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* Device: Ultrasound Cardiac Output Monitor (USCOM 1A)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 26 Weeks
Maximum Age: 44 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy preterm neonate<br>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. | Device: Ultrasound Cardiac Output Monitor (USCOM 1A)<br>* 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)<br>* Other names: NONIN Equanox near-infrared spectroscope;|
| Healthy term neonate<br>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. | Device: Ultrasound Cardiac Output Monitor (USCOM 1A)<br>* 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)<br>* Other names: NONIN Equanox near-infrared spectroscope;|
| Sick neonate<br>Neonate of any gestation, without congenital heart defects, with clinically and laboratory-identified infection. | Device: Ultrasound Cardiac Output Monitor (USCOM 1A)<br>* 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)<br>* Other names: NONIN Equanox near-infrared spectroscope;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight measurement | weight in grams | 1 minute | 
| Height measurement | length in centimeters | 1 minute | 
| Chest and head circumference | Chest and head circumference in centimeters | 1 minute | 
| Blood pressure measurement | non- invasive arterial blood pressure measurement in mmHg | 1 minute | 
| Pulse rate measurement | pulse rate in beats per minute | 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 | 15-20 minutes | 
| Echocardioscopy for left ventricular outflow tract diameter | Echocardiography for left ventricular outflow tract diameter in centimeters | 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. | 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 | 3-5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac output; echocardiography; USCOM; neonates