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ECCI Recommendations.

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Recommendations from the Second Meeting of the European Congenital CMV Initiative (ECCI) (revised June 20th, 2006)

Veyrier-du-Lac (France)
April 8-9 April 2006

These recommendations are a consensus statement from the European Congenital CMV Initiative (ECCI). This group is composed of virologists, epidemiologists, immunologists, obstetricians and paediatricians whose aim is to promote awareness of congenital CMV and support and encourage research initiatives into this important infection. Many of our members have been involved with research into CMV and its effects during pregnancy for many years and are international experts in this field.

Education

1. Women of child bearing age should be informed about the natural history of CMV, and in particular, the risk of CMV infection in pregnancy (click here for more details.)

2. Women should also be informed about:

- hygienic measures which could prevent CMV infection during pregnancy (click here for more details.)
- benefits and limitations of antenatal and neonatal CMV testing (click here for more details.).

Management in Pregnancy

3. If women who are aware of the natural history of CMV and are informed about CMV testing request testing, this should not be denied. (click here for more details.)
4. When investigating possible cases of primary CMV infection during pregnancy, the most sensitive and specific diagnostic tests should be offered. (click here for more details.)

5. In a case of confirmed primary infection, investigations in a centre specialized in fetal diagnosis should be offered and the possibility of invasive prenatal diagnosis to detect fetal infection should be discussed. (click here for more details.)

6. Markers able to predict which fetuses are at high risk of developing congenital disease should be developed. (click here for more details.)

Treatment in Pregnancy

7. At present, there is no established treatment of pregnant women with CMV infection to prevent congenital infection. (click here for more details.)

8. Controlled clinical trials should be conducted to identify safe and effective treatments for CMV during pregnancy. (click here for more details.)

Newborns

9. Health Authorities should be more aware of the medical, social and financial burden to families and society caused by congenital CMV and should consider introducing screening programmes in the future (click here for more details.)

10. Health Authorities should consider linking tests for congenital CMV infection to existing screening programmes for hearing loss as a measure of CMV damage in the population. (click here for more details.)

11. Laboratory tests for congenital CMV screening of newborns should be further developed and validated when a successful treatment for congenital CMV infection or other beneficial interventions to mitigate the effects of congenital CMV becomes available ((see also recommendation 15) (click here for more details.)

12. For retrospective diagnosis of congenital infection, we recommend that CMV DNA should be detected by PCR in dried blood spots stored on Guthrie Cards. To facilitate this, dried blood spots from all newborns should be stored for a minimum of five years. (click here for more details.)

12a. Infected newborns, both symptomatic and asymptomatic at birth, should be enrolled in a clinical and instrumental follow-up to ensure prompt recognition and correction of any damage (click here for more details.)

12b. Markers should be developed which are able to identify newborns at high risk of developing damages that could be avoided when a successful treatment becomes available (click here for more details.)

Treatment of Newborns

13. We recommend that congenitally infected neonates born with symptoms of CMV disease involving the central nervous system be offered treatment with intravenous ganciclovir according to the protocol from the Collaborative Antiviral Study Group described in Kimberlin D, et al. J Pediatrics; 143:16-25, 2003 (click here for more details.)

14. While waiting for the formal results of prospective studies on the use of valganciclovir, individual cases with symptomatic congenital CMV could be treated by open label use of this drug with close clinical, pharmacokinetic and virological monitoring. A registry should be established to follow the long term development of these children, including the possibility of identifying long term toxicity from antiviral drugs. (click here for more details.)

Screening

15. Presently, congenital CMV infection does not satisfy all criteria for introduction of routine neonatal screening (click here for more details.). However, ECCI considers congenital CMV infection sufficiently serious to justify a future screening programme and will work to eliminate technical barriers and to standardise screening tests at maximum sensitivity and specificity (see also recommendation 11) (click here for more details.).

16. Presently, congenital CMV infection does not satisfy all criteria for introduction of routine antenatal screening (click here for more details.). However, ECCI will work to define the best conditions for:
- correct serological identification of CMV seronegative women (in order to inform them about hygienic measures) (see recommendation 2)
- safe serological identification of women undergoing primary CMV infection in pregnancy (in order to counsel them about the risk of fetal infection, as well as the means to detect and the nowadays discussed measures to prevent fetal infection) (see recommendations 4-6)


Vaccine

17. We strongly recommend that vaccine development should proceed as rapidly as possible. (click here for more details.)


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