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

• Conditions: Echocardiography of Newborns

• Registration Number: NCT04307043
• Lead Sponsor: Peking University Third Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-05
• Status Verified: 2020-03
• Study First Submitted: 2020-03-11
• Study First Submitted QC: 2020-03-11
• Last Update Submitted: 2020-03-11
• Study First Posted: 2020-03-13
• Last Update Posted: 2020-03-13
• Primary Completion: 2020-12-31
• Study Completion: 2021-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China