Non-invasive Measurement of Neonatal Central and Peripheral Hemodynamics (NInHeDyNeo)

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

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.

Study Overview

• Status: Completed
• Conditions: Neonatal Infection; Pre-Term
• Intervention / Treatment: Device: Ultrasound Cardiac Output Monitor (USCOM 1A)

• Study Type: Observational
• Enrollment (Actual): 163

Contacts and Locations

Study Locations

• Lithuania
  • Vilnius, Lithuania, 08464
    • Vilnius University, Neonatology Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study enrolled both preterm and full-term newborns of any gestational age, 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 in control group.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy preterm neonate; 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); 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
Healthy term neonate; 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); 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
Sick neonate; Neonate of any gestation, without congenital heart defects, with clinically and laboratory-identified infection.	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); Other Names: GE LOGIQ S8 XDclear 2.0 ultrasound system with S4-10-D (3-9MHz) probe; NONIN Equanox near-infrared spectroscope

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vilnius University
• Investigators: Study Director: Vytautas Usonis, MD, Vilnius University

Publications and helpful links

General Publications

• Pliauckiene A, Liubsys A, Vankeviciene R, Usonis V. Ultrasonic cardiac output monitor provides effective non-invasive bedside measurements of neonatal cardiac output. J Clin Monit Comput. 2022 Jun;36(3):803-807. doi: 10.1007/s10877-021-00711-2. Epub 2021 Apr 30.

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2017
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: November 18, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 16, 2019

Study Record Updates

• Last Update Posted (Actual): April 21, 2021
• Last Update Submitted That Met QC Criteria: April 20, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: cardiac output; echocardiography; USCOM; neonates
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: NCPKV-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No