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

P

Peking University

Status

Unknown

Conditions

Echocardiography of Newborns

Study type

Observational

Funder types

Other

Identifiers

NCT04307043
bysypediatric2020-1

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

Under 12 weeks old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

400 participants in 2 patient groups

postnatal age
General information and echocardiographic data
Description:
General information:(1)Record the gestational age, birth weight, length, delivery way, Apgar score, maternal pregnancy status, prenatal bleeding or not after admission.(2)PS use, ventilator mode, other illness and complications should be recorded during hospitalization. (3) Record the baby's heart rate, respiratory rate, blood pressure, body surface area on every check.

Trial contacts and locations

1

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Central trial contact

Yunfeng Liu, MD; Danfang LU, MD

Data sourced from clinicaltrials.gov

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