Early Postnatal Management of Gestational Brain Sonographic Malformations.

Completed

• Conditions: Brain Abnormalities
• Interventions: Other: No intervention

• Registration Number: NCT04293302
• Lead Sponsor: Hillel Yaffe Medical Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-02-29
• Study First Submitted QC: 2020-02-29
• Study Start: 2020-03-01
• Study First Posted: 2020-03-03
• Status Verified: 2021-08
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Last Update Submitted: 2022-08-17
• Last Update Posted: 2022-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

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

Exclusion Criteria

• Prematurity

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No brain abnormality	No intervention	Newborn who did not have any gestational brain sonographic abnormality
Brain abnormality	No intervention	Newborn who had any gestational brain sonographic abnormality

Primary Outcome Measures

Name	Time	Method
Any postnatal clinical neurologic or sonographic brain abnormality	10 years	Post natal sonographic brain abnormality or clinical neurologic abnormality

Trial Locations

Locations (1)

Neonatal intensive care unit, Hillel Yaffe medical center; 🇮🇱 Hadera, Israel