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,
(Biotest AG, Dreieich, Germany) administration in pregnant
women with the acute phase of primary CMV infection for pre-
vention of intrauterine transmission. This experimental study
began in February 2010 in Italy, enrolment ended in March
2011 and the study will be completed in December 2011.
A second multicentre study (Cytotect
study) was
designed as a phase 3 prospective trial in congenital CMV
infection for the evaluation of the efcacy of CMV-specic
hyperimmune globulin Cytotect
Therapy
Follow-up at 12, 24 months of life and yearly
untilsixthyear
Follow-up at 6 months of life
CMV Real Time PCR in blood
Follow-up at 3 months of life
Laboratory investigations;
Long-term follow-up
CMV Real Time PCR in blood and urine
(at 12 months);
Physical, neurological and anthropometric
evaluation;
Neurodevelopmental evaluation;
and urine;
Laboratory investigations;
Physical, neurological and
anthropometric evaluation;
Neurodevelopmental