Consequences and Risk factors Of congenital CytomegalovirUS infectio

Completed

• Conditions: congenital CMV infection; congenital cytomegalovirus infection; 10029299; 10047438; 10010335

• Registration Number: NL-OMON39637
• Lead Sponsor: RIVM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 25000

Inclusion Criteria

- Children who underwent neonatal screening and of whom the dried blood spot is stored for 5 years. (Phase 1, n <= 25.000)
- Children with a congenital CMV infection and a twice as large control group without congenital CMV infection as detected by PCR (polymerase chain reaction) analysis of the dried blood spot. (Phase 2, n <= 300)

Exclusion Criteria

- Children who did not participate in neonatal screening
- Chidren whose dried blood spots are not stored for 5 years
- No informed consent of parents for testing the dried blood spots or participation in the study

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Hearing function at the age of 5 to 6 years</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Neonatal hearing function and cognitive function, motor function, visual<br /><br>function and growth during childhood (0 to 6 years)<br /><br>- Quality of life of the children (at the age of 5 to 6 years) and of their<br /><br>parents.<br /><br>- Viral load of CMV in the dried blood spots.<br /><br><br /><br>Additional study:<br /><br>- Predictive factors for the outcome of congenital CMV infection.</p><br>