Development of Potential Biomarkers for Foetal Brain Development After Congenital CMV Infection
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|ClinicalTrials.gov Identifier: NCT03188679|
Recruitment Status : Not yet recruiting
First Posted : June 15, 2017
Last Update Posted : June 15, 2017
Cytomegalovirus (CMV) is the most common cause of congenital infection, with approximately 0.5% of pregnant women being infected during pregnancy. CMV transmission to the fetus occurs in about one third of women who are infected in first trimester. Babies infected before birth are at risk for serious neurological complications such as intellectual disability, seizures, deafness, and even death. Most couples facing a diagnosis of congenital cytomegalovirus infection in their unborn baby focus heavily on the predicted neurological outcome for their child. To date, methods to assess brain development in fetuses have been mainly limited to detecting structural brain abnormalities by ultrasound. However, these ultrasound signs may not become apparent until very late in pregnancy, and some neurological disability is not accompanied by any structural brain changes. More research on methods of predicting neurodevelopmental outcome independent of structural brain malformations before third trimester is urgently needed.
The purpose of this study is to investigate a new method of studying the health of unborn babies using amniotic fluid. Amniocentesis is often performed after maternal CMV infection to diagnose fetal infection. Prior research by Dr Hui has demonstrated that cell free RNA in amniotic fluid can provide meaningful information from multiple organs including the fetal brain. The investigators propose to collect and analyse a small sample of amniotic fluid to detect which genes are turned "on" or "off" (gene expression) in a fetus that has a congenital CMV infection, compared to those without any infection.
The genes that are differentially expressed in CMV infected fetuses will then be analysed to provide information on the broad physiological processes that are altered due to the infection ("functional analysis") and identify neurodevelopmental gene transcripts of interest for future studies ("biomarker discovery").
|Condition or disease||Intervention/treatment||Phase|
|Cytomegalovirus Infections Neurologic Dysfunction||Device: amniocentesis||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patients with seroconversion for CMV undergo amniocentesis. RNA markers for neurological outcome in amniotic fluid CMV PCR negative foetuses are compared with those with amniotic fluid CMV positive PCR.|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Development of Potential Biomarkers for Foetal Brain Development After Congenital CMV Infection|
|Estimated Study Start Date :||July 2017|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||December 2019|
amniotic fluid for patients with CMV seroconversion during pregnancy will undergo mRNA sequencing
mRNA sequencing on amniotic fluid samples of fetuses after maternal seroconversion for CMV
Other Name: mRNA sequencing
- gene expression in amniotic fluid after CMV seroconversion [ Time Frame: 30 months ]That fetuses infected with CMV will have an altered gene expression profile compared with noninfected fetuses, as ascertained in amniotic fluid cell-free RNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03188679
|Contact: Luc E De Catte, MD, PhD||016 34 84 firstname.lastname@example.org|
|Principal Investigator:||Lisa Hui, MD, PhD||Melbourne University|