Actively Recruiting

Age: 0 - 10Years
All Genders
NCT05855889

Observational Study of the Management of Infants With Congenital CMV

Led by St George's, University of London · Updated on 2023-05-23

200

Participants Needed

1

Research Sites

785 weeks

Total Duration

On this page

Sponsors

S

St George's, University of London

Lead Sponsor

E

European Society for Paediatric Infectious Diseases

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is an observational, prospective/retrospective multicentre, cohort study of children diagnosed with cCMV. This study will contribute to a wider study also recruiting participants in Europe and other countries worldwide. No investigations or treatment will be carried out that are not part of routine clinical practice. Infants with cCMV are routinely followed up from an infectious diseases, audiology, ophthalmology and neurodevelopmental perspective until approximately 6 years of age, or longer if there are ongoing issues. Some children will be retrospectively diagnosed with cCMV in later childhood. Recruitment can be from any centre that manages these patients and has agreed to participate in the study.

CONDITIONS

Official Title

Observational Study of the Management of Infants With Congenital CMV

Who Can Participate

Age: 0 - 10Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients of any sex diagnosed with congenital CMV infection
  • Diagnosis confirmed by CMV DNA PCR or viral culture in urine, saliva, blood, or cerebrospinal fluid within first 21 days of life
  • Children diagnosed retrospectively by positive CMV DNA PCR in dried blood spots collected within 21 days of life
  • Diagnosis by positive CMV DNA PCR in dried umbilical cord blood or donated/stored umbilical cord blood
  • Children whose parents or guardians provide informed consent
  • Age less than 11 years
Not Eligible

You will not qualify if you...

  • Refusal to provide written informed consent by parents or legal guardian

AI-Screening

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Trial Site Locations

Total: 1 location

1

St George's University of London

London, United Kingdom, SW17 0RE

Actively Recruiting

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Research Team

S

Sana Ibrahim, BSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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