Early Postnatal Management of Gestational Brain Sonographic Malformations.

NCT ID: NCT04293302

Last Updated: 2022-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-12-31

Brief Summary

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Gestational sonographic follow up may find some brain malformations. The trial is about to characterize these findings and correlate with the immediate postnatal findings.

Detailed Description

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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.

Conditions

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Brain Abnormalities

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Brain abnormality

Newborn who had any gestational brain sonographic abnormality

No intervention

Intervention Type OTHER

No intervention

No brain abnormality

Newborn who did not have any gestational brain sonographic abnormality

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Prematurity
Maximum Eligible Age

1 Week

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Erez Nadir, MD

Senior Neonatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erez Nadir, MD

Role: STUDY_CHAIR

Hillel Yaffe Medical Center

Locations

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Neonatal intensive care unit, Hillel Yaffe medical center

Hadera, , Israel

Site Status

Countries

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Israel

References

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Ghi T, Carletti A, Contro E, Cera E, Falco P, Tagliavini G, Michelacci L, Tani G, Youssef A, Bonasoni P, Rizzo N, Pelusi G, Pilu G. Prenatal diagnosis and outcome of partial agenesis and hypoplasia of the corpus callosum. Ultrasound Obstet Gynecol. 2010 Jan;35(1):35-41. doi: 10.1002/uog.7489.

Reference Type BACKGROUND
PMID: 20020466 (View on PubMed)

Other Identifiers

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0162-19-HYMC

Identifier Type: -

Identifier Source: org_study_id

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