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

NCT ID: NCT04307043

Last Updated: 2020-03-13

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-05

Study Completion Date

2021-03-31

Brief Summary

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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

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Conditions

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Echocardiography of Newborns

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* 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.
Maximum Eligible Age

12 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dan Fang Lu

Attending physician

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Danfang LU, MD

Role: CONTACT

15811091481

Yunfeng Liu, MD

Role: CONTACT

13520694100

Facility Contacts

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Danfang Lu, MD

Role: primary

15811091481

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.

Reference Type BACKGROUND
PMID: 27908646 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26321355 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28687889 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29910578 (View on PubMed)

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.

Reference Type RESULT
PMID: 25753503 (View on PubMed)

Other Identifiers

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bysypediatric2020-1

Identifier Type: -

Identifier Source: org_study_id

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