|- candidate number||13240|
|- NTR Number||NTR3582|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-aug-2012|
|- Secondary IDs||NL 39787.058.12 CCMO|
|- Public Title||Onderzoek naar de gevolgen van aangeboren cytomegalovirus infectie in Nederland.|
|- Scientific Title||Consequences and Risk factors Of congenital CytomegalovirUS infection.|
|- hypothesis||Congenital cytomegalovirus infection can cause long term sequelae including hearing loss and cognitive impairment.|
|- Healt Condition(s) or Problem(s) studied||Congenital Cytomegalovirus (CMV)infection, Sensorineural Hearing Loss|
|- 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.
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).
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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||17-sep-2012|
|- planned closingdate||1-jan-2015|
|- Target number of participants||300|
|- 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).
|- Timepoints||Retrospective collection of data:|
1. At the age of 5 or 6 years;
2. During early childhood (< 4 years);
3. At neonatal screening.
|- Trial web site||www.rivm.nl/crocus (not yet available)|
|- CONTACT FOR PUBLIC QUERIES|| M.J. Korndewal|
|- CONTACT for SCIENTIFIC QUERIES|| M.J. Korndewal|
|- Sponsor/Initiator ||National Institute for Public Health and the Environment (RIVM), Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|Strategic Research RIVM (SOR)|
|- Brief 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.
|- Main changes (audit trail)|
|- RECORD||16-aug-2012 - 12-sep-2012|