Non-invasive Measurement of Neonatal Central and Peripheral Hemodynamics

Completed

• Conditions: Neonatal Infection; Pre-Term
• Interventions: Device: Ultrasound Cardiac Output Monitor (USCOM 1A)

• Registration Number: NCT04200807
• Lead Sponsor: Vilnius University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-12
• Study First Submitted: 2019-11-18
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-16
• Status Verified: 2020-09
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30
• Last Update Submitted: 2021-04-20
• Last Update Posted: 2021-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sick neonate	Ultrasound Cardiac Output Monitor (USCOM 1A)	Neonate of any gestation, without congenital heart defects, with clinically and laboratory-identified infection.
Healthy preterm neonate	Ultrasound Cardiac Output Monitor (USCOM 1A)	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.
Healthy term neonate	Ultrasound Cardiac Output Monitor (USCOM 1A)	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.

Primary Outcome Measures

Name	Time	Method
Weight measurement	1 minute	weight in grams
Height measurement	1 minute	length in centimeters
Echocardioscopy to measure velocity time integral	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	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	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	1 minute	Chest and head circumference in centimeters
Blood pressure measurement	1 minute	non- invasive arterial blood pressure measurement in mmHg
Pulse rate measurement	1 minute	pulse rate in beats per minute
Echocardioscopy for left ventricular outflow tract diameter	2-3 minutes	Echocardiography for left ventricular outflow tract diameter in centimeters

Trial Locations

Locations (1)

Vilnius University, Neonatology Centre; 🇱🇹 Vilnius, Lithuania