Clinical trial NCT03722615: Epidemiology of Congenital Cytomegalovirus in a High HIV Prevalence Setting, South Africa
Official title: Epidemiology of Congenital Cytomegalovirus in a High HIV Prevalence Setting, South Africa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cytomegalovirus Congenital
Hearing Loss
Neurodevelopmental Disorders
Immunogenicity
Neonatal Death
Stillbirth
Lead sponsor: University of Witwatersrand, South Africa
Sponsor class: OTHER
First posted: 2018-10-29
Enrollment: 3000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborns of women aged 18 years or older born at Chris Hani Baragwanath Academic hospital in the Johannesburg area enrolled in V98_28OBTP (NCT02215226).

Stillbirths and Neonatal deaths at Chris Hani Baragwanath Academic hospital in the Johannesburg area.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Mother's age ≥18y
* Residing in Soweto and would be available for study follow-up
* Consents to enrol self and baby in study

Exclusion Criteria:

- Mother not enrolled in V98_28OBTP (NCT02215226)

Primary outcomes:
measure: Prevalence of congenital cytomegalovirus infection in HIV exposed and HIV unexposed newborns
timeFrame: May 2016 - December 2016
measure: Incidence of sensorineural hearing loss in congenital CMV infected and uninfected infants, assessed by visual reinforced audiometry
timeFrame: May 2016 - May 2019
measure: Incidence of neurodevelopmental delay in congenital CMV infected and uninfected children at one year of age assessed by scores obtained in the Bayley III developmental assessment tool.
timeFrame: May 2017 to March 2018
Secondary outcomes:
measure: Prevalence of CMV infection in stillbirths and neonatal deaths
timeFrame: July 2015 to August 2016
measure: Immunogenicity to primary series of childhood vaccinations in congenital CMV infected and uninfected children
timeFrame: October 2016 to February 2018
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Respiratory and Meningeal Pathogen Research Unit, Soweto
Study officials:
affiliation: Univeristy of Witwatersrand, South Africa
name: Shabir A Madhi
role: STUDY_DIRECTOR
References: