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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03188679
Recruitment Status : Not yet recruiting
First Posted : June 15, 2017
Last Update Posted : June 15, 2017
University of Melbourne
Information provided by (Responsible Party):
prof. dr. Luc De Catte, Universitaire Ziekenhuizen Leuven

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").

Condition or disease Intervention/treatment Phase
Cytomegalovirus Infections Neurologic Dysfunction Device: amniocentesis Not Applicable

  Show Detailed Description

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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

Arm Intervention/treatment
mRNA sequencing
amniotic fluid for patients with CMV seroconversion during pregnancy will undergo mRNA sequencing
Device: amniocentesis
mRNA sequencing on amniotic fluid samples of fetuses after maternal seroconversion for CMV
Other Name: mRNA sequencing

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03188679

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Contact: Luc E De Catte, MD, PhD 016 34 84 38

Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
University of Melbourne
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Principal Investigator: Lisa Hui, MD, PhD Melbourne University

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Responsible Party: prof. dr. Luc De Catte, Head of Fetal Medicine, Universitaire Ziekenhuizen Leuven Identifier: NCT03188679     History of Changes
Other Study ID Numbers: S58404
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: June 15, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data on pregnancy outcome (birth weight, gestational age at birth, Apgar score) and neonatal development in relation to CMV infection (clinical signs relevant to neonatal CMV infection: jaundice, petechia, hepatosplenomegaly, neurological impairment, hearing deficit, visual impairment) will be recorded. Dat will be availabe within six months after delivery. Data will be obtained from the digitalised patient records.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by prof. dr. Luc De Catte, Universitaire Ziekenhuizen Leuven:
neurological impairment
outcome prediction
amniotic fluid biomarkers

Additional relevant MeSH terms:
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Communicable Diseases
Cytomegalovirus Infections
Neurologic Manifestations
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Nervous System Diseases
Signs and Symptoms