Assesment of Olfactory Disorders and Performance of a New Olfactory Test in Children With Congenital CMV (INFECSMELL)
Assesment of Olfactory Disorders and Performance of a New Olfactory Test in Children With Congenital Cytomegalovirus Infection
Study Overview
Status
Conditions
Intervention / Treatment
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 hearing impairment is of major interest for children because it will allow the early use of a hearing aid minimizing the impact of these deficits on the cognitive development.
The study hypothesis is that a link might exist between hearing deficits and olfactory deficits in these children due to viral lesions on the two sensory systems. Thus early exploration of olfaction might allow early detection of starting deterioration of hearing or predict the occurrence of deafness. Moreover, this exploration is easy, non invasive, fast to set up and adapted to very young children. No study has hitherto assessed the impact of congenital CMV infection on olfaction.
The proportion of children with olfactory deficits will be assessed among children with congenital CMV infection, using parts of a discrimination test of simple odorants (Sniffin' Sticks, Burghardt, Wedel, Germany). The performances of a new olfactory test developed by the investigators that uses binary mixtures of odorants, will also be assessed. These tests of nasal chemosensory performance are based on pen-like odor dispensing devices and measure odor discrimination ability of young children in less than 15 min. Finally, this study aims at demonstrate, if it exists, the association between olfactory deficits and hearing loss in children with congenital CMV infection.
This study will be conducted in 80 patients and 40 healthy subjects (3-10years). The healthy children will be matched for age and gender. Selection will be made based on medical records during the course of standard care visit. After collection of informed consent, olfactory tests will be performed.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Le Kremlin-Bicêtre, France, 94270
- Hôpital Bicêtre
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Paris, France, 75019
- Robert Debre Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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CMV symptomatic at birth
olfactory tests, otoacoustic emissions (OAE)
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Two series of olfactory tests will be performed : 1) the first one with simple odorants and 2) the second one with binary mixtures of odorants.
These tests of nasal chemosensory performance are based on pen-like odor dispensing devices (Sniffin' Sticks, Burghardt, Wedel, Germany) and measure odor discrimination ability of young children in less than 15 min.
|
|
CMV asymptomatic at birth
olfactory tests, otoacoustic emissions (OAE)
|
Two series of olfactory tests will be performed : 1) the first one with simple odorants and 2) the second one with binary mixtures of odorants.
These tests of nasal chemosensory performance are based on pen-like odor dispensing devices (Sniffin' Sticks, Burghardt, Wedel, Germany) and measure odor discrimination ability of young children in less than 15 min.
|
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Healthy controls
olfactory tests, otoacoustic emissions (OAE)
|
Two series of olfactory tests will be performed : 1) the first one with simple odorants and 2) the second one with binary mixtures of odorants.
These tests of nasal chemosensory performance are based on pen-like odor dispensing devices (Sniffin' Sticks, Burghardt, Wedel, Germany) and measure odor discrimination ability of young children in less than 15 min.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Percentage of children with olfactory disorders among children with congenital CMV infection.
Time Frame: Inclusion visit
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Inclusion visit
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Françoise LAZARINI, PhD, Institut Pasteur, Paris France
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-091
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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