Fetal cytomegalovirus syndrome

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1FDA treatments22Specialists8Treatment centers1Financial resources

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Overview

Fetal cytomegalovirus (CMV) syndrome, also known as congenital cytomegalovirus infection, is a condition caused by transmission of cytomegalovirus from a pregnant mother to the developing fetus, most commonly during a primary maternal CMV infection. It is one of the most common congenital infections worldwide and a leading non-genetic cause of sensorineural hearing loss and neurodevelopmental disability in children. The virus can affect multiple organ systems, including the central nervous system, liver, hematopoietic system, eyes, and inner ear. Key clinical features of symptomatic congenital CMV include intrauterine growth restriction, microcephaly, intracranial calcifications (often periventricular), ventriculomegaly, sensorineural hearing loss, chorioretinitis, hepatosplenomegaly, jaundice, thrombocytopenia, and petechiae (a blueberry muffin rash). Neurological involvement can lead to intellectual disability, seizures, and motor deficits. Importantly, approximately 85-90% of infants with congenital CMV infection are asymptomatic at birth, though a proportion of these may develop late-onset sequelae, particularly sensorineural hearing loss, during the first years of life. Treatment for symptomatic congenital CMV infection includes antiviral therapy with valganciclovir (or intravenous ganciclovir), which has been shown to improve hearing and neurodevelopmental outcomes when initiated within the first month of life and continued for six months. Supportive care, including audiological monitoring, ophthalmological follow-up, and developmental assessments, is essential for all affected children. Prevention strategies focus on hygiene education for pregnant women, and research into CMV vaccines is ongoing. Prenatal diagnosis can be made through detection of CMV DNA in amniotic fluid by polymerase chain reaction (PCR), typically performed after 21 weeks of gestation.

Also known as:

Clinical phenotype terms— hover any for plain English:

Conjugated hyperbilirubinemiaHP:0002908ChorioretinitisHP:0012424Retinal hemorrhageHP:0000573
Age of Onset

Neonatal

Begins at or shortly after birth (first 4 weeks)

Orphanet ↗NORD ↗

FDA & Trial Timeline

8 events
Feb 2026Evaluation of Long-term Efficacy of 4 to 6-month Course Antiviral Therapy for Neurodevelopmental Impairments Caused by Congenital Cytomegalovirus Infection

Hu Bofei — PHASE4

TrialNOT YET RECRUITING
Apr 2025Evaluation of Software for Interpreting Virological Results Indicated for the Diagnosis of Cytomegalovirus (CMV) Infection During Pregnancy and Intended for Health Professionals

Assistance Publique - Hôpitaux de Paris

TrialRECRUITING
Feb 2025A Safety Assessment of Oral Letermovir in Infants With Symptomatic Congenital Cytomegalovirus

National Institute of Allergy and Infectious Diseases (NIAID) — PHASE1

TrialRECRUITING
Oct 2023Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Versus Valaciclovir

Assistance Publique - Hôpitaux de Paris — PHASE3

TrialRECRUITING
Aug 2023Cytomegalovirus (CMV) Transmission and Immune Tracking (TransmIT) Study

University of Massachusetts, Worcester

TrialRECRUITING
Apr 2022Congenital CYtoMEgalovirus Infection in VIEtnam (CYMEVIE)

Hanoi Obstetrics and Gynecology Hospital

TrialRECRUITING
Jan 2021Prenatal Behavioral Intervention to Prevent Maternal Cytomegalovirus (CMV) in Pregnancy

University of Alabama at Birmingham — NA

TrialACTIVE NOT RECRUITING
Mar 1996

Vitrasert Implant: FDA approved

Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome.

FDAcompleted

Data sourced from FDA regulatory filings and ClinicalTrials.gov. Updated periodically.

Treatments

1 available

Vitrasert Implant

Ganciclovir intravitreal implant· Bausch & Lomb Surgical, Chiron Vision ProductsOrphan Drug

Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome.

No actively recruiting trials found for Fetal cytomegalovirus syndrome at this time.

New trials open frequently. Follow this disease to get notified.

Search ClinicalTrials.gov ↗Join the Fetal cytomegalovirus syndrome community →

Specialists

22 foundView all specialists →
RP
Rebecca Clifton, PhD
GEORGETOWN, IN
Specialist
PI on 2 active trials
MM
Monica Longo, MD
FALLS CHURCH, VA
Specialist
PI on 2 active trials
AD
Ann CTM Vossen, Dr.
Specialist
PI on 1 active trial
AD
Anne Marie Oudesluys - Murphy, Prof. Dr.
Specialist
PI on 1 active trial
KD
Keren Shahar-Nissan, Dr
Specialist
PI on 1 active trial
LM
Laura Gibson, MD
Specialist
PI on 1 active trial1 Fetal cytomegalovirus syndrome publication
HM
Ha Nguyen Thi Thu, MD.PhD
Specialist
PI on 1 active trial
MP
Marianne Leruez-Ville, M.D., PhD
Specialist
PI on 1 active trial
AM
Anh Nguyen Duy, MD.PhD
Specialist
PI on 1 active trial
MM
Marianne Leruez-Ville, MD.PhD
Specialist
PI on 1 active trial
LM
Linh Dinh Thuy, MD.PhD
Specialist
PI on 1 active trial
JP
Jun Zhang, Professor
Specialist
PI on 3 active trials
JP
Jacques Fourgeaud, Pharma.D., PhD
Specialist
PI on 1 active trial
MS
Mike Sharland
DULUTH, MN
Specialist
PI on 1 active trial24 Fetal cytomegalovirus syndrome publications
FP
Françoise LAZARINI, PhD
Specialist
PI on 2 active trials
MP
Marianne Leruez-Ville, MD, PhD
Specialist
PI on 2 active trials
MM
Marcela Rodriguez, MD
Specialist
PI on 1 active trial
JB
Janet Berrington
Specialist
PI on 1 active trial12 Fetal cytomegalovirus syndrome publications
SM
Shabir A Madhi
Specialist
PI on 1 active trial18 Fetal cytomegalovirus syndrome publications
BM
Brenna Anderson, MD
GERMANTOWN, MD
Specialist
PI on 1 active trial
LM
Laurence Bussieres, MD
Specialist
PI on 1 active trial1 Fetal cytomegalovirus syndrome publication
SL
Suzanne Luck
GLEN ALLEN, VA
Specialist
PI on 1 active trial28 Fetal cytomegalovirus syndrome publications

Treatment Centers

8 centers
🏥 NORD

Baylor College of Medicine Rare Disease Center

Baylor College of Medicine

📍 Houston, TX

🏥 NORD

Stanford Medicine Rare Disease Center

Stanford Medicine

📍 Stanford, CA

🔬 UDN

NIH Clinical Center Undiagnosed Diseases Program

National Institutes of Health

📍 Bethesda, MD

🔬 UDN

UCLA UDN Clinical Site

UCLA Health

📍 Los Angeles, CA

🔬 UDN

Baylor College of Medicine UDN Clinical Site

Baylor College of Medicine

📍 Houston, TX

🔬 UDN

Harvard/MGH UDN Clinical Site

Massachusetts General Hospital

📍 Boston, MA

🏥 NORD

Mayo Clinic Center for Individualized Medicine

Mayo Clinic

📍 Rochester, MN

👤 Mayo Clinic Center for Individualized Medicine

🏥 NORD

UCLA Rare Disease Day Program

UCLA Health

📍 Los Angeles, CA

Financial Resources

1 resources

Livtencity

Takeda

Cytomegalovirus Infection

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copay card
Copay CardPatient Assistance
Accepting applications

Travel Grants

No travel grants are currently matched to Fetal cytomegalovirus syndrome.

Search all travel grants →NORD Financial Assistance ↗

Community

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Latest news about Fetal cytomegalovirus syndrome

Disease timeline:

New recruiting trial: Evaluation of Software for Interpreting Virological Results Indicated for the Diagnosis of Cytomegalovirus (CMV) Infection During Pregnancy and Intended for Health Professionals

A new clinical trial is recruiting patients for Fetal cytomegalovirus syndrome

New recruiting trial: A Safety Assessment of Oral Letermovir in Infants With Symptomatic Congenital Cytomegalovirus

A new clinical trial is recruiting patients for Fetal cytomegalovirus syndrome

New recruiting trial: Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Versus Valaciclovir

A new clinical trial is recruiting patients for Fetal cytomegalovirus syndrome

New recruiting trial: Cytomegalovirus (CMV) Transmission and Immune Tracking (TransmIT) Study

A new clinical trial is recruiting patients for Fetal cytomegalovirus syndrome

New recruiting trial: Congenital CYtoMEgalovirus Infection in VIEtnam (CYMEVIE)

A new clinical trial is recruiting patients for Fetal cytomegalovirus syndrome

Caregiver Resources

NORD Caregiver Resources

Support, advocacy, and financial assistance for caregivers of rare disease patients.

Mental Health Support

Rare disease caregiving can be isolating. Connect with counseling and peer support.

Family & Caregiver Grants

Financial assistance programs specifically for caregivers of rare disease patients.

Social Security Disability

Learn how rare disease patients may qualify for SSDI/SSI benefits.

Common questions about Fetal cytomegalovirus syndrome

What is Fetal cytomegalovirus syndrome?

Fetal cytomegalovirus (CMV) syndrome, also known as congenital cytomegalovirus infection, is a condition caused by transmission of cytomegalovirus from a pregnant mother to the developing fetus, most commonly during a primary maternal CMV infection. It is one of the most common congenital infections worldwide and a leading non-genetic cause of sensorineural hearing loss and neurodevelopmental disability in children. The virus can affect multiple organ systems, including the central nervous system, liver, hematopoietic system, eyes, and inner ear. Key clinical features of symptomatic congenita

At what age does Fetal cytomegalovirus syndrome typically begin?

Typical onset of Fetal cytomegalovirus syndrome is neonatal. Age of onset can vary across affected individuals.

Which specialists treat Fetal cytomegalovirus syndrome?

22 specialists and care centers treating Fetal cytomegalovirus syndrome are listed on UniteRare, sourced from ClinicalTrials.gov principal investigators, published research, and the NPPES NPI registry.

What treatment and support options exist for Fetal cytomegalovirus syndrome?

2 patient support programs are currently tracked on UniteRare for Fetal cytomegalovirus syndrome. See the treatments and support programs sections for copay assistance, eligibility, and contact details.