Early Postnatal Management of Gestational Brain Sonographic Malformations.

August 17, 2022 updated by: Erez Nadir, MD, Hillel Yaffe Medical Center
Gestational sonographic follow up may find some brain malformations. The trial is about to characterize these findings and correlate with the immediate postnatal findings.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Gestational sonographic follow up may find some brain malformations (such as ventricular enlargement, agenesis of corpus callosum, etc.).The trial is about to characterize these findings and correlate with the immediate postnatal findings.

Study Type

Observational

Enrollment (Actual)

350

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

  • Israel
      • Hadera, Israel, 38100
        • Neonatal intensive care unit, Hillel Yaffe medical center

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 1 week (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All infants who were born in Hillel Yaffe medical center during 2010-2019

Description

Inclusion Criteria:

  • All term newborn infants who underwent a neurologic consultation or brain ultrasound.

Exclusion Criteria:

  • Prematurity

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
Intervention / Treatment
Brain abnormality
Newborn who had any gestational brain sonographic abnormality
Other: No intervention
No intervention
No brain abnormality
Newborn who did not have any gestational brain sonographic abnormality
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Any postnatal clinical neurologic or sonographic brain abnormality
Time Frame: 10 years
Post natal sonographic brain abnormality or clinical neurologic abnormality
10 years

Collaborators and Investigators

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

Sponsor

Hillel Yaffe Medical Center

Investigators

  • Study Chair: Erez Nadir, MD, Hillel Yaffe Medical Center

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)

March 1, 2020

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

February 29, 2020

First Submitted That Met QC Criteria

February 29, 2020

First Posted (Actual)

March 3, 2020

Study Record Updates

Last Update Posted (Actual)

August 18, 2022

Last Update Submitted That Met QC Criteria

August 17, 2022

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0162-19-HYMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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