Non-invasive Measurement of Neonatal Central and Peripheral Hemodynamics

NCT04200807 | Completed

• 1 other identifier: NCPKV-2017
• Study Type: observational
• Target: 163
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-Term; Neonatal Infection

Keywords

cardiac output; echocardiography; USCOM; neonates

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (3)

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)

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)

Sick neonate

Neonate of any gestation, without congenital heart defects, with clinically and laboratory-identified infection.

Device: Ultrasound Cardiac Output Monitor (USCOM 1A)

Interventions

Ultrasound Cardiac Output Monitor (USCOM 1A) DEVICE

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)

Also known as: GE LOGIQ S8 XDclear 2.0 ultrasound system with S4-10-D (3-9MHz) probe, NONIN Equanox near-infrared spectroscope

Healthy preterm neonate; Healthy term neonate; Sick neonate

Eligibility Criteria

• Age: 26 Weeks - 44 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• newborns of any gestational age
• parental consent acquired

You may not qualify if:

• congenital malformations
• hemodynamic instability in control group
• any respiratory support in control group
• infection in control group

Sponsors & Collaborators

• Vilnius University: lead

Study Sites (1)

Vilnius University, Neonatology Centre

Vilnius, 08464, Lithuania

Location

Related Publications (1)

• 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.

  PMID: 33929641 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Vytautas Usonis, MD

  Vilnius University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: December 16, 2019
• Study Start: September 12, 2017
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: April 21, 2021

Record last verified: 2020-09

Locations

LI (1)