Status:
COMPLETED
Assesment of Olfactory Disorders and Performance of a New Olfactory Test in Children With Congenital CMV
Lead Sponsor:
Institut Pasteur
Conditions:
Congenital Cytomegalovirus Infection
Eligibility:
All Genders
3-10 years
Brief Summary
CMV lesions were found in the olfactory system of children with congenital CMV infection but no study has hitherto examined the impact of congenital CMV infection on olfaction. So the investigators pr...
Detailed Description
Cytomegalovirus (CMV) is the first cause of congenital deafness resulting from viral infection. Hearing loss may occur several years after birth in childhood and be often progressive. Detection of hea...
Eligibility Criteria
Inclusion
- Children ≥ 3 years old and ≤ 10 years old
- Oral consent of the child to participate in the study
- Written informed consent of the two parents
- Congenital CMV infection : 1) asymptomatic form at birth and 2) symptomatic form at birth. The latter is defined by the presence of at least one of the following clinical signs: growth retardation, prematurity,petechiae, splenomegaly, thrombocytopenia, jaundice, low number of platelets, ictere, digestive disorders ...
- NOTE: CMV diagnosis is made on the following criteria: positive CMV PCR in urine and / or blood in the first 3 weeks of life or retrospective diagnosis on the presence of a positive PCR on the Guthrie test performed at 3-7 days of life.
Exclusion
- Medical care incompatible with the objective of the study,
- Patient who would object to the protocol
- No clinical condition that may interfere with the study, e.g.: no chronic sinusitis, nasopharyngitis, etc.
Key Trial Info
Start Date :
May 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 2 2020
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT02782988
Start Date
May 1 2016
End Date
May 2 2020
Last Update
July 27 2021
Active Locations (2)
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1
Hopital Bicêtre
Le Kremlin-Bicêtre, France, 94270
2
Robert Debré Hospital
Paris, France, 75019