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

Vilnius University

Status: Completed

Conditions: Pre-Term; Neonatal Infection

Treatments: Device: Ultrasound Cardiac Output Monitor (USCOM 1A)

Study type: Observational

Funder types: Other

Identifiers

NCT04200807

NCPKV-2017

Details and patient eligibility

About

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.

Enrollment: 163 patients

Sex: All

Ages: 26 to 44 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

163 participants in 3 patient groups

Healthy preterm neonate

Description:

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.

Treatment:

Device: Ultrasound Cardiac Output Monitor (USCOM 1A)

Healthy term neonate

Description:

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.

Treatment:

Device: Ultrasound Cardiac Output Monitor (USCOM 1A)

Sick neonate

Description:

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

Treatment:

Device: Ultrasound Cardiac Output Monitor (USCOM 1A)