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Automated Fetal Cardiac Function in Babies Affected by Heart Diseases

NCT05698277 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 495

Last updated 2024-12-10

No results posted yet for this study

Summary

The goal of this international multicentre prospective observational cohort study with a nested case-control study is to test some automated fetal heart functional parameters in healthy babies compared to those affected by a congenital heart condition.

The main questions it aims to answer are:

* If there is a significant difference between the two populations of infants
* Whether these parameters could significantly improve the predictive value of actual cardiovascular profile score to predict hydrops Participants will be offered two automated cardiac function assessments between 27+6 and 29+6 gestational weeks and between 34+6 and 36+6 weeks of gestation. Functional parameters will be compared between the two study groups and evaluated over time.

Conditions

  • Congenital Heart Defect
  • Cardiac Function

Interventions

DIAGNOSTIC_TEST

Automated fetal cardiac function evaluation

Evaluation of ultrasound parameters by automated algorithms. Ultrasound assessed parameters are: 1. Pulsed wave Doppler Modified Left and Right Myocardial performance indices 2. Spatio-temporal image correlation Tricuspid, Mitral and Septal Annular Plane Systolic Excursion

Sponsors & Collaborators

  • Centre Hospitalier de Mayotte

    collaborator OTHER

  • Vittore Buzzi Children's Hospital

    collaborator OTHER

  • San Salvatore Hospital of L'Aquila

    collaborator OTHER

  • Institute for Maternal and Child Health IRCCS Burlo Garofolo

    collaborator UNKNOWN

  • Sheba Medical Center

    collaborator OTHER_GOV

  • Clinic of Fetal Echocardiography, Medical Centre UJASTEK

    collaborator UNKNOWN

  • Anna Erenbourg

    lead OTHER

Principal Investigators

  • Anna Erenbourg, MD · The University of New South Wales

  • Alec W Welsh, MD PhD · The University of New South Wales

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2028-01-01
Completion
2028-02-01

Countries

  • Australia
  • Israel
  • Italy
  • Mayotte
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05698277 on ClinicalTrials.gov