Clinical trial NCT04307043: Study on the Geometric Parameters and Hemodynamic Reference Range of Neonatal Heart.
Official title: Prospective Study on Geometric Parameters and Hemodynamic Reference Range of Neonatal Heart.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Echocardiography of Newborns
Keywords: Echocardiography, Heart, Neonatal, Reference range
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 400
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Babies born in the obstetrics department of Peking University Third Hospital and admitted to the neonatal ward.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Reference range of cardiac geometric parameters of preterm infants based on different gestational ages, weights, days of age and body surface area.
timeFrame: 0 day of life to PMA 36 weeks
measure: Hemodynamic changes in full-term and preterm infants on 0~7days of life.
timeFrame: 0~7days of life
Secondary outcomes:
measure: Reference range of cardiac geometric parameters of full-term infants based on different weights, days of age and body surface area.
timeFrame: 0~7days of life
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Yunfeng Liu, MD
role: STUDY_DIRECTOR
References:
citation: Jain A, El-Khuffash AF, Kuipers BCW, Mohamed A, Connelly KA, McNamara PJ, Jankov RP, Mertens L. Left Ventricular Function in Healthy Term Neonates During the Transitional Period. J Pediatr. 2017 Mar;182:197-203.e2. doi: 10.1016/j.jpeds.2016.11.003. Epub 2016 Nov 28.
citation: Abushaban L, Vel MT, Rathinasamy J, Sharma PN. Normal Reference Ranges for Cardiac Valve Annulus in Preterm Infants. Pediatr Cardiol. 2016 Jan;37(1):112-9. doi: 10.1007/s00246-015-1247-9. Epub 2015 Sep 1.
citation: Abushaban L, Vel MT, Rathinasamy J, Sharma PN. Normal Reference Ranges for Pulmonary Artery Diameters in Preterm Infants. Pediatr Cardiol. 2017 Oct;38(7):1377-1384. doi: 10.1007/s00246-017-1673-y. Epub 2017 Jul 7.
citation: Abushaban L, Mariappa TV, Rathinasamy J, Sharma PN. Normal reference ranges for aortic diameters in preterm infants. J Saudi Heart Assoc. 2018 Apr;30(2):86-94. doi: 10.1016/j.jsha.2017.09.003. Epub 2017 Oct 1.
citation: Levy PT, Dioneda B, Holland MR, Sekarski TJ, Lee CK, Mathur A, Cade WT, Cahill AG, Hamvas A, Singh GK. Right ventricular function in preterm and term neonates: reference values for right ventricle areas and fractional area of change. J Am Soc Echocardiogr. 2015 May;28(5):559-69. doi: 10.1016/j.echo.2015.01.024. Epub 2015 Mar 7.