Study on the Geometric Parameters and Hemodynamic Reference Range of Neonatal Heart.

Prospective Study on Geometric Parameters and Hemodynamic Reference Range of Neonatal Heart.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04307043

Enrollment

400

Registered

2020-03-13

Start date

2020-02-05

Completion date

2021-03-31

Last updated

2020-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Echocardiography of Newborns

Keywords

Echocardiography, Heart, Neonatal, Reference range

Brief summary

Perform bedside echocardiography on neonates (term and preterm infants) who were admitted to our neonatal department within 24 hours of birth, and establish a geometric reference range of neonatal cardiac ultrasound and explore the hemodynamic changes of early newborns. Bedside echocardiography were performed to measure the diameter of each heart cavity and large vessels, velocity of each valve and aorta, wall thickness, left ventricular systolic function, right heart Tei index, Tricuspid Annular Plane Systolic Excursion(TPASE) of term and preterm infants respectively on 0 day, 3d, 7d of life and postmenstrual age of 30 weeks, 32 weeks, 34 weeks and 36 weeks.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 12 Weeks

Healthy volunteers

Yes

Inclusion criteria

* 1\. Infants with normal hearts (infants with small patent fora-men oval or small patent ductus arteriosus were not excluded). 2.Healthy preterm infant with no evidence of sepsis, renal failure. 3. Absence of other major congenital anomalies or syndromes 4. Prior written consent was obtained from the parents.

Exclusion criteria

* Infants with severe congenital malformations, either cardiac or non-cardiac.

Design outcomes

Primary

Measure	Time frame
Reference range of cardiac geometric parameters of preterm infants based on different gestational ages, weights, days of age and body surface area.	0 day of life to PMA 36 weeks
Hemodynamic changes in full-term and preterm infants on 0~7days of life.	0~7days of life

Secondary

Measure	Time frame
Reference range of cardiac geometric parameters of full-term infants based on different weights, days of age and body surface area.	0~7days of life

Countries

China

Contacts

Primary ContactDanfang LU, MD

ldf0612@163.com15811091481

Backup ContactYunfeng Liu, MD

liuyunfeng96@163.com13520694100

Outcome results