No registrations found.
ID
Source
Brief title
Health condition
Congenital Cytomegalovirus (CMV)infection / Aangeboren CMV infectie
Sensorineural Hearing Loss / Perceptief gehoorsverlies
Sponsors and support
- Leiden University Medical Center (LUMC)
Intervention
Outcome measures
Primary outcome
Sensorineural Hearing Loss (at the age of 5 or 6 years) determined by audiometric testing in an audiological center.
Secondary outcome
1. Visual impairment (at the age of 5 or 6 years and in early childhood) determined by visual testing with Landolt-C-test during preventive health check (5-6 yr) and ‘VOV’-test, APK-TOV-test and Landolt-C-test during the child health centre visits (0-4 yr);
2. Cognitive impairment (at the age of 5 or 6 years and in early childhood) determined by a parent development questionnaire (CDI: child development inventory) and school results from the student tracking system (5-6 yr) and by the ‘van Wiechenonderzoek’ during the child health centre visits (0-4 yr);
3. Motor impairment (at the age of 5 or 6 years and in early childhood) determined by a parent development questionnaire (CDI: child development inventory), the Baecke-Fassaert motor test during preventive health check (5-6 yr) and by the ‘van Wiechenonderzoek’ during the child health centre visits (0-4 yr);
4. Sensorineural Hearing Loss (during neonatal hearing screening) determined by audiometric testing in an audiological center (< 1 yr);
5. Growth: Height and weight measurement during the preventive health check (5-6 yr) and the child health centre visits (0-4 yr).
Background summary
Retrospective Observational Cohort study on the burden of disease of congenitale cytomegalovirus infecton.
Phase 1. Testing of 25.000 dried blood spots of children (4 to 5 years old), with informed consent of parents, on congenital cytomegalovirus infection using polymerase chain reaction (PCR).
Phase 2. Inclusion of 100 children with congenital cytomegalovirus and 200 controls and determining the long term sequelae using information from parents and youth health care.
Study objective
Congenital cytomegalovirus infection can cause long term sequelae including hearing loss and cognitive impairment.
Study design
Retrospective collection of data:
1. At the age of 5 or 6 years;
2. During early childhood (< 4 years);
3. At neonatal screening.
Intervention
N/A
Department of Epidemiology and Surveillance<br>
Postbus 1
M.J. Korndewal
Bilthoven 3720 BA
The Netherlands
+31 (0)30 2748516
marjolein.korndewal@rivm.nl
Department of Epidemiology and Surveillance<br>
Postbus 1
M.J. Korndewal
Bilthoven 3720 BA
The Netherlands
+31 (0)30 2748516
marjolein.korndewal@rivm.nl
Inclusion criteria
Phase 1:
1. Children between 4 and 5 years of age, born between January and September 2008 and living in the Netherlands, whose DBS from the neonatal screening are stored for 5 years.
Phase 2:
1. All children with congenital CMV infection, established by a positive PCR analysis for CMV in the DBS from the neonatal screening;
2. A (twice as large) control group of children without congenital CMV infection, established by a negative PCR analysis for CMV, matched for age (month of birth), gender and region.
Exclusion criteria
Phase 1:
1. Children who did not participate in neonatal screening;
2. Children whose dried blood spots are not stored for 5 years;
3. No informed consent from one of the parents (or the legal representative if applicable).
Phase 2:
1. No informed consent from both parents (or the legal representative if applicable);
2. Children with missing data of the PCR for CMV on the DBS.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3431 |
| NTR-old | NTR3582 |
| CCMO | NL39787.058.12 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON39637 |