Early Postnatal Management of Gestational Brain Sonographic Malformations.

Brain Abnormalities Clinical Trial

Official title:

Early Postnatal Management of Gestational Brain Sonographic Malformations.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04293302
• Other study ID #: 0162-19-HYMC
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2021
• Source: Hillel Yaffe Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 1 Week

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Prematurity

Related Conditions & MeSH terms

• Brain Abnormalities
• Congenital Abnormalities

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Israel	Neonatal intensive care unit, Hillel Yaffe medical center	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any postnatal clinical neurologic or sonographic brain abnormality	Post natal sonographic brain abnormality or clinical neurologic abnormality	10 years