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Clinical Trials/NCT04307043
NCT04307043
Unknown
Not Applicable

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

Peking University Third Hospital1 site in 1 country400 target enrollmentFebruary 5, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Echocardiography of Newborns
Sponsor
Peking University Third Hospital
Enrollment
400
Locations
1
Primary Endpoint
Reference range of cardiac geometric parameters of preterm infants based on different gestational ages, weights, days of age and body surface area.
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 5, 2020
End Date
March 31, 2021
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dan Fang Lu

Attending physician

Peking University Third Hospital

Eligibility Criteria

Inclusion Criteria

  • 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.
  • Absence of other major congenital anomalies or syndromes
  • Prior written consent was obtained from the parents.

Exclusion Criteria

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

Outcomes

Primary Outcomes

Reference range of cardiac geometric parameters of preterm infants based on different gestational ages, weights, days of age and body surface area.

Time Frame: 0 day of life to PMA 36 weeks

Hemodynamic changes in full-term and preterm infants on 0~7days of life.

Time Frame: 0~7days of life

Secondary Outcomes

  • 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)

Study Sites (1)

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