Study on the Geometric Parameters and Hemodynamic Reference Range of Neonatal Heart.
NCT ID: NCT04307043
Last Updated: 2020-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
400 participants
OBSERVATIONAL
2020-02-05
2021-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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postnatal age
No interventions assigned to this group
General information and echocardiographic data
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
12 Weeks
ALL
Yes
Sponsors
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Peking University Third Hospital
OTHER
Responsible Party
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Dan Fang Lu
Attending physician
Principal Investigators
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Yunfeng Liu, MD
Role: STUDY_DIRECTOR
Peking University Third Hospital
Locations
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Peking University Third Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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bysypediatric2020-1
Identifier Type: -
Identifier Source: org_study_id
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