Non-invasive Measurement of Neonatal Central and Peripheral Hemodynamics

Neonatal Infection Clinical Trial

— NInHeDyNeo  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04200807
• Other study ID #: NCPKV-2017
• Status: Completed
• Start date: September 12, 2017
• Est. completion date: September 30, 2020

Study information

• Verified date: September 2020
• Source: Vilnius University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 26 Weeks to 44 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Infection
• Pre-Term
• Premature Birth

Intervention

Device:
• Ultrasound 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)

Locations

Country	Name	City	State
Lithuania	Vilnius University, Neonatology Centre	Vilnius

Sponsors (1)

Lead Sponsor	Collaborator
Vilnius University

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight measurement	weight in grams	1 minute
Primary	Height measurement	length in centimeters	1 minute
Primary	Chest and head circumference	Chest and head circumference in centimeters	1 minute
Primary	Blood pressure measurement	non- invasive arterial blood pressure measurement in mmHg	1 minute
Primary	Pulse rate measurement	pulse rate in beats per minute	1 minute
Primary	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
Primary	Echocardioscopy for left ventricular outflow tract diameter	Echocardiography for left ventricular outflow tract diameter in centimeters	2-3 minutes
Primary	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
Primary	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