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

This study has been completed.
Sponsor:
Collaborators:
Shiba Medical Center
Tel Aviv Medical Center
Information provided by:
Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT00872703
First received: March 30, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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.


Condition
CMV
Prenatal Diagnosis
Ultrasound
MRI

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Does Normal Brain Imaging Predict Normal Neurodevelopmental Outcome in Fetuses With Proven Cytomegalovirus Infection?

Resource links provided by NLM:


Further study details as provided by Wolfson Medical Center:

Primary Outcome Measures:
  • neuropsychological outcome [ Time Frame: 1-7 years ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: January 2008
Study Completion Date: February 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   1 Year to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Children of woman with CMV proved intrauterine infections

Criteria

Inclusion Criteria:

  • CMV PCR positive in the amniotic fluid

Exclusion Criteria:

  • US abnormal findings during fetal life
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00872703

Locations
Israel
E. Wolfson Medical Center
Holon, Israel, 58000
Sponsors and Collaborators
Wolfson Medical Center
Shiba Medical Center
Tel Aviv Medical Center
  More Information

No publications provided

Responsible Party: Gustavo Malinger, MD, Director OB-GYN Ultrasound Unit
ClinicalTrials.gov Identifier: NCT00872703     History of Changes
Other Study ID Numbers: SR-907
Study First Received: March 30, 2009
Last Updated: March 30, 2009
Health Authority: Israel: Ministery of Health

Keywords provided by Wolfson Medical Center:
CMV
Prenatal Diagnosis
Ultrasound
MRI

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 02, 2014