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

Ultrasound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00872703
• Other study ID #: SR-907
• Status: Completed
• Phase: N/A
• First received: March 30, 2009
• Last updated: March 30, 2009
• Start date: January 2008
• Est. completion date: February 2009

Study information

• Verified date: March 2009
• Source: Wolfson Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministery of Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 7 Years

Eligibility

Inclusion Criteria:

• CMV PCR positive in the amniotic fluid

Exclusion Criteria:

• US abnormal findings during fetal life

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• CMV
• Cytomegalovirus Infections
• MRI
• Prenatal Diagnosis
• Ultrasound

Locations

Country	Name	City	State
Israel	E. Wolfson Medical Center	Holon

Sponsors (3)

Lead Sponsor	Collaborator
Wolfson Medical Center	Shiba Medical Center, Tel Aviv Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neuropsychological outcome		1-7 years	No