Does Normal Brain Imaging Predict Normal Neurodevelopmental Outcome in Fetuses With Proven Cytomegalovirus Infection?

NCT ID: NCT00872703

Last Updated: 2009-03-31

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

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-02-28

Brief Summary

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Cytomegalovirus (CMV) is the largest member of the virus family Herpesviridae that infects almost all humans at some point in their lives (Ross, 2004). Congenital CMV infection is most likely to occur when the mother experiences a primary infection during pregnancy, and it is much less common in cases of reactivation of the disease or infection by a different CMV strain (Boppana 1999, Endres 2001). The prevalence of congenital CMV infection varies between 0.15-2.2% (Ross 2004, Ross 2006, Malm 2007). While most infants born with congenital CMV infection are asymptomatic, 10 to 15% show clinical findings at birth (Ross 2004).

It is generally agreed that congenital CMV infection, whether it is symptomatic or not, is a major risk factor for perceptual deficits. However, its influence on children's future neuropsychological functioning is less well established. Symptomatic congenital CMV infection is a major risk factor for poor developmental outcome (Williamson 1982, Kylat 2006, Dollard 2007), but the available data regarding neuropsychological outcome for asymptomatic children is extremely diverse (Conboy 1986, Ivarson 1997, Kashdan 1998, Temple 2000, Zhang 2007).

We evaluated the neuropsychological outcome of children with congenital cytomegalovirus (CMV) infection and normal consecutive fetal neurosonographic examinations and determined whether Magnetic Resonance Imaging (MRI) provided additional information in these cases.

Detailed Description

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Conditions

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CMV Prenatal Diagnosis Ultrasound MRI

Keywords

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CMV Prenatal Diagnosis Ultrasound MRI

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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1

No interventions assigned to this group

2

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* CMV PCR positive in the amniotic fluid

Exclusion Criteria

* US abnormal findings during fetal life
Minimum Eligible Age

1 Year

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role collaborator

Tel Aviv Medical Center

OTHER

Sponsor Role collaborator

Wolfson Medical Center

OTHER_GOV

Sponsor Role lead

Locations

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E. Wolfson Medical Center

Holon, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SR-907

Identifier Type: -

Identifier Source: org_study_id