Postnatal Managemant of Prenetal Cardiac Echogenic Foci i... | NCT04265352

Studies
Postnatal Managemant of Prenetal Cardiac Echogenic Foci in Hillel Yaffe Medical Center

NCT04265352

Sponsor

Hillel Yaffe Medical Center

Status

Completed

Last Update Posted

Aug 17, 2021Actual

Enrollment

120Actual

Phase

Not provided

Conditions

Prenatal Diagnosis

Interventions

No intervension

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

Jan 8, 2020

First Submission Date that Met QC Criteria

Feb 10, 2020

First Posted Date

Feb 11, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2021

Last Update Posted Date

Aug 17, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Erez Nadir, MD, Principal investigator, Hillel Yaffe Medical CenterPrincipal Investigator

Lead Sponsor

Hillel Yaffe Medical CenterOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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. The investigator will review all echographies performed in the last ten years. Reviewing the data collected until now may reduce the need for poist natal echography.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prenetal cardiac echogenic focus		Newborn infants who had prenatal cardiac echogenic focus	Other: No intervension

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervension	Other	There is intervention at all.	Prenetal cardiac echogenic focus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Any sonographic cardiac pathologic finding exists	Any sonographic cardiac pathologic finding exists, as defined by the cardiologist who performs the postnatal echocardiography.	2 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

14 Days

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erez Nadir, MD	Hillel Yaffe Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe medical center		Hadera	Hadera	38100	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22708618	Background	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.