Research overview
We are conducting a prospective observational study of asymptomatic congenital cytomegalovirus (CMV) infection, led by the Department of Pediatrics at Nagoya University, the Second Department of Pediatrics at Ogaki Municipal Hospital, and collaborating facilities. The study population includes infants with no abnormalities identified during the fetal or perinatal period who were
found to have positive urinary cytomegalovirus on screening tests, including self-funded
screening.
Among infants with no apparent abnormalities during the fetal period, some are found to have clinical findings only after detailed examinations such as automated auditory brainstem response (AABR), brain MRI, or fundoscopic examination. Therefore, when urinary cytomegalovirus testing is positive, these comprehensive evaluations are required.
It is estimated that approximately 10% of individuals with asymptomatic congenital cytomegalovirus infection develop late-onset symptoms. However, in the past, asymptomatic cases could not be diagnosed at birth; therefore, it is likely that some individuals classified as “asymptomatic” may actually have had unrecognized findings that would have been detected through detailed examinations.Accordingly, the objectives of this study are as follows:
- To perform detailed evaluations in infants who tested positive through self-funded screening in order to determine whether any symptoms are present, and to initiate treatment for those found to have clinical manifestations.
- To observe the long-term outcomes of infants who are diagnosed as truly asymptomatic after comprehensive evaluation, and to determine the accurate incidence of late-onset symptoms.
- To collect urine and blood samples at birth and investigate potential biomarkers that may predict the future development of symptoms.
We are conducting a prospective observational study of asymptomatic congenital cytomegalovirus (CMV) infection, led by the Department of Pediatrics at Nagoya University, the Second Department of Pediatrics at Ogaki Municipal Hospital, and collaborating facilities. The study population includes infants with no abnormalities identified during the fetal or perinatal period who were found to have positive urinary cytomegalovirus on screening tests, including self-funded screening.
Among infants with no apparent abnormalities during the fetal period, some are found to have clinical findings only after detailed examinations such as automated auditory brainstem response (AABR), brain MRI, or fundoscopic examination. Therefore, when urinary cytomegalovirus testing is positive, these comprehensive evaluations are required.
It is estimated that approximately 10%
of individuals with asymptomatic congenital cytomegalovirus infection develop late-onset symptoms. However, in the past, asymptomatic cases could not be diagnosed at birth; therefore, it is likely that some individuals classified as “asymptomatic” may actually have had unrecognized findings that would have been detected through detailed examinations.Accordingly, the objectives of this study are as follows:
- To perform detailed evaluations in infants who tested positive through self-funded screening in order to determine whether any symptoms are present, and to initiate treatment for those found to have clinical manifestations.
- To observe the long-term outcomes of infants who are diagnosed as truly asymptomatic after comprehensive evaluation, and to determine the accurate incidence of late-onset symptoms.
- To collect urine and blood samples at birth and investigate potential biomarkers that may predict the future development of symptoms.
Flow of this research
If you would like to know more about this study
(This study is conducted only in Japan.)
Please contact us through the application form.
Please contact us through the application
form.