NCT04293302

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 29, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

August 18, 2022

Status Verified

August 1, 2021

Enrollment Period

1.8 years

First QC Date

February 29, 2020

Last Update Submit

August 17, 2022

Conditions

Brain Abnormalities

Outcome Measures

Primary Outcomes (1)

  • Any postnatal clinical neurologic or sonographic brain abnormality

    Post natal sonographic brain abnormality or clinical neurologic abnormality

    10 years

Study Arms (2)

Brain abnormality

Newborn who had any gestational brain sonographic abnormality

Other: No intervention

No brain abnormality

Newborn who did not have any gestational brain sonographic abnormality

Other: No intervention

Interventions

No interventionOTHER

No intervention

Brain abnormalityNo brain abnormality

Eligibility Criteria

AgeUp to 1 Week
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Prematurity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neonatal intensive care unit, Hillel Yaffe medical center

Hadera, 38100, Israel

Location

Related 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.

    PMID: 20020466BACKGROUND

Study Officials

  • Erez Nadir, MD

    Hillel Yaffe Medical Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Neonatologist

Study Record Dates

First Submitted

February 29, 2020

First Posted

March 3, 2020

Study Start

March 1, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

August 18, 2022

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)