NCT04265352

Brief Summary

Cardiac echogenic foci are common finding on prenatal follow-up. At hillel Yaffe medical center a post natal echography is performed to all newborns with prenatal cardiac echogenic foci. Reviewing the data collected until now may reduce the need for poist natal echography.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

1 year

First QC Date

January 8, 2020

Last Update Submit

August 16, 2021

Conditions

Prenatal Diagnosis

Keywords

cardiac echogenic focus

Outcome Measures

Primary Outcomes (1)

  • Any sonographic cardiac pathologic finding exists

    Any sonographic cardiac pathologic finding exists, as defined by the cardiologist who performs the postnatal echocardiography.

    2 weeks

Study Arms (1)

Prenetal cardiac echogenic focus

Newborn infants who had prenatal cardiac echogenic focus

Other: No intervension

Interventions

No intervensionOTHER

There is intervention at all.

Prenetal cardiac echogenic focus

Eligibility Criteria

AgeUp to 14 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Newborn infants at hillle Yaffe medical center during 10 years: 2010-2019

You may qualify if:

  • Newborns who had a cardiac echogenic focus during prenatal pollow-up.

You may not qualify if:

  • Newborns who did not had postnatal echocardiography due to technical reasons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe medical center

Hadera, Hadera, 38100, Israel

Location

Related Publications (1)

  • Shakoor S, Ismail H, Munim S. Intracardiac echogenic focus and fetal outcome - review of cases from a tertiary care centre in Karachi, Pakistan. J Matern Fetal Neonatal Med. 2013 Jan;26(1):2-4. doi: 10.3109/14767058.2012.703724. Epub 2012 Jul 13.

    PMID: 22708618BACKGROUND

Study Officials

  • Erez Nadir, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 8, 2020

First Posted

February 11, 2020

Study Start

January 1, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

August 17, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Will not be shared

Locations

IL(1)