Congenital cytomegalovirus infection can cause long term sequelae including hearing loss and cognitive impairment.
ID
Bron
Verkorte titel
Aandoening
Congenital Cytomegalovirus (CMV)infection / Aangeboren CMV infectie
Sensorineural Hearing Loss / Perceptief gehoorsverlies
Ondersteuning
- Leiden University Medical Center (LUMC)
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Sensorineural Hearing Loss (at the age of 5 or 6 years) determined by audiometric testing in an audiological center.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Congenital cytomegalovirus infection can cause long term sequelae including hearing loss and cognitive impairment.
Onderzoeksopzet
Retrospective collection of data:
1. At the age of 5 or 6 years;
2. During early childhood (< 4 years);
3. At neonatal screening.
Onderzoeksproduct en/of interventie
N/A
Algemeen / deelnemers
Department of Epidemiology and Surveillance<br>
Postbus 1
M.J. Korndewal
Bilthoven 3720 BA
The Netherlands
+31 (0)30 2748516
marjolein.korndewal@rivm.nl
Wetenschappers
Department of Epidemiology and Surveillance<br>
Postbus 1
M.J. Korndewal
Bilthoven 3720 BA
The Netherlands
+31 (0)30 2748516
marjolein.korndewal@rivm.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3431 |
| NTR-old | NTR3582 |
| CCMO | NL39787.058.12 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON39637 |