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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43495

Enrollment

100

Registered

2016-04-19

Start date

2016-05-17

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

congenital cytomegalovirus infection

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

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

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)

Design outcomes

Primary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results