Hearing Loss Clinical Trial
Official title:
Epidemiology of Congenital Cytomegalovirus in a High HIV Prevalence Setting, South Africa
The aim of this project is to determine the epidemiology of congenital cytomegalovirus (CMV)
infection and incidence of subsequent permanent neurological sequelae in a high HIV prevalent
setting in Soweto, Johannesburg. A cross-sectional study will be conducted on mother-infant
pairs, screening mothers for CMV infection and newborns for congenital CMV infection.
Maternal CMV prevalence will be determined by testing for CMV specific antibodies in blood.
Newborn congenital infection will be determined by polymerase chain reaction (PCR) tests on
newborn saliva and urine within 3 weeks of birth. Various risk factors associated with
congenital CMV such as HIV exposure, and gestational age will be assessed. The association
between maternal vaginal CMV shedding postnatally with congenital CMV infection will be
explored by swabbing maternal vaginal fluid and conducting quantitative CMV PCR analysis.
Newborns confirmed with congenital CMV and a control group of uninfected newborns will form a
cohort to be followed up until 12 months of age monitoring for various neurological sequelae
such as hearing loss, neurodevelopmental impairment, ocular damage, cerebral damage and
seizures.
A comparison of vaccine immune responses between cases of congenital CMV and the CMV
uninfected infants to the primary series of vaccines in the National Expanded Programme on
Immunisation will be compared. The contribution of CMV infection to neonatal death and
stillbirths will be described by minimally invasive tissue sampling (MITS) for CMV on babies
that die during the neonatal period and stillbirths.
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