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

March 11, 2020 updated by: Dan Fang Lu, Peking University Third Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Babies born in the obstetrics department of Peking University Third Hospital and admitted to the neonatal ward.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
postnatal age
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
0~7days of life

Secondary Outcome Measures

Outcome Measure
Time Frame
Reference range of cardiac geometric parameters of full-term infants based on different weights, days of age and body surface area.
Time Frame: 0~7days of life
0~7days of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Investigators

  • Study Director: Yunfeng Liu, MD, Peking University Third Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2020

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

March 31, 2021

Study Registration Dates

First Submitted

March 11, 2020

First Submitted That Met QC Criteria

March 11, 2020

First Posted (Actual)

March 13, 2020

Study Record Updates

Last Update Posted (Actual)

March 13, 2020

Last Update Submitted That Met QC Criteria

March 11, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • bysypediatric2020-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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