Development of Potential Biomarkers for Foetal Brain Development After Congenital CMV Infection

NCT03188679 | Unknown

• 1 other identifier: S58404
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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").

Conditions

Cytomegalovirus Infections; Neurologic Dysfunction

Keywords

CMV; neurological impairment; outcome prediction; amniotic fluid biomarkers

Outcome Measures

Primary Outcomes (1)

• gene expression in amniotic fluid after CMV seroconversion

  That fetuses infected with CMV will have an altered gene expression profile compared with noninfected fetuses, as ascertained in amniotic fluid cell-free RNA

  30 months

Study Arms (1)

mRNA sequencing

OTHER

amniotic fluid for patients with CMV seroconversion during pregnancy will undergo mRNA sequencing

Device: amniocentesis

Interventions

amniocentesis DEVICE

mRNA sequencing on amniotic fluid samples of fetuses after maternal seroconversion for CMV

Also known as: mRNA sequencing

mRNA sequencing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women with evidence of maternal primary CMV infection during pregnancy
• Fetuses with structural abnormalities suggestive of congenital CMV infection
• all patients consent to amniocentesis
• age 18 years or over and capable of giving informed consent

You may not qualify if:

• Women who do not give consent
• not capable of consent for medical procedures
• language barrier
• under 18 years of age.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• University of Melbourne: collaborator

MeSH Terms

Conditions

Cytomegalovirus Infections; Neurologic Manifestations

Interventions

Amniocentesis

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Paracentesis; Specimen Handling; Prenatal Diagnosis; Diagnostic Techniques, Obstetrical and Gynecological; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Lisa Hui, MD, PhD

  Melbourne University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luc E De Catte, MD, PhD

CONTACT

016 34 84 38; luc.decatte@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Fetal Medicine

Model Details: 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.

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 15, 2017
• Study Start: July 1, 2017
• Primary Completion: July 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 15, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share