Markers for neurocognitive impairment in congenitally CMV infected infants: MARVELYS study

Completed

Conditions: 10007951
congenital cytomegalovirus infection
10040792
10047438

Registration Number: NL-OMON43495

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

•Positive Polymerase Chain Reaction (PCR) detection of the CMV in urine or blood in neonates younger than 10 days of life and/or positive CMV PCR in dried blood spot (Guthriecard) in children older than 10 days of age
•Age: birth - three months of age
•Written informed consent from the parent(s) or guardian(s).

Exclusion Criteria

•No signed consent from the parent(s) or guardian(s).
•MRI contra-indications (e.g. implanted active devices such as pacemakers or medication pumps)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main endpoints are neurocognitive performance, deviations in neuroimaging<br /><br>parameters, audiological and ophthalmological measurements at the age of one,<br /><br>two, five and eight years of age. CSF and blood parameters will be measured and<br /><br>correlated to the results of the above mentioned tests.<br /><br>We expect to find various immunological, neurological host factors and<br /><br>virological factors predictive of poor neurological and cognitive outcome in<br /><br>our study group.<br /><br>The results of this study may have direct implications for the direct patient<br /><br>care of these children, as they may need timely alterations in medical<br /><br>treatment and/or referral for supportive therapy.</p><br>

Secondary Outcome Measures