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

NCT00872703 | Completed

• 1 other identifier: SR-907
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CMV; Prenatal Diagnosis; Ultrasound; MRI

Keywords

CMV; Prenatal Diagnosis; Ultrasound; MRI

Outcome Measures

Primary Outcomes (1)

• neuropsychological outcome

  1-7 years

Study Arms (2)

1

2

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children of woman with CMV proved intrauterine infections

You may qualify if:

• CMV PCR positive in the amniotic fluid

You may not qualify if:

• US abnormal findings during fetal life

Sponsors & Collaborators

• Wolfson Medical Center: lead
• Sheba Medical Center: collaborator
• Tel Aviv Medical Center: collaborator

Study Sites (1)

E. Wolfson Medical Center

Holon, 58000, Israel

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: March 30, 2009
• First Posted: March 31, 2009
• Study Start: January 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: February 1, 2009
• Last Updated: March 31, 2009

Record last verified: 2009-03

Locations

IL (1)