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Assesment of Olfactory Disorders and Performance of a New Olfactory Test in Children With Congenital CMV (INFECSMELL)

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ClinicalTrials.gov Identifier: NCT02782988
Recruitment Status : Recruiting
First Posted : May 26, 2016
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Institut Pasteur

Tracking Information
First Submitted Date May 23, 2016
First Posted Date May 26, 2016
Last Update Posted Date August 14, 2018
Study Start Date May 2016
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 25, 2016)
Percentage of children with olfactory disorders among children with congenital CMV infection. [ Time Frame: Inclusion visit ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02782988 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assesment of Olfactory Disorders and Performance of a New Olfactory Test in Children With Congenital CMV
Official Title Assesment of Olfactory Disorders and Performance of a New Olfactory Test in Children With Congenital Cytomegalovirus Infection
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 propose in this study to assess the proportion of children with olfactory deficits among children with congenital CMV infection. Second this study will also evaluate performances of a new olfactory test, based on discrimination of binary odorant mixtures.
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 Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 80 children with congenital CMV infection will be included in a monocentre study : 40 children which symptomatic CMV infection at birth and 40 children with asymptomatic form of infection at birth. To evaluate the performance of the new olfactory test, 40 controlled healthy children matched for age and gender will also be included.
Condition Congenital Cytomegalovirus Infection
Intervention Other: 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.
Study Groups/Cohorts
  • CMV symptomatic at birth
    olfactory tests, otoacoustic emissions (OAE)
    Intervention: Other: olfactory tests, otoacoustic emissions (OAE)
  • CMV asymptomatic at birth
    olfactory tests, otoacoustic emissions (OAE)
    Intervention: Other: olfactory tests, otoacoustic emissions (OAE)
  • Healthy controls
    olfactory tests, otoacoustic emissions (OAE)
    Intervention: Other: olfactory tests, otoacoustic emissions (OAE)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 25, 2016)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Years to 10 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts
Contact: Natacha TEISSIER, MD, PhD + 33 (0) 1 40 03 53 67 natacha.teissier@aphp.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02782988
Other Study ID Numbers 2015-091
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Institut Pasteur
Study Sponsor Institut Pasteur
Collaborators Not Provided
Investigators
Study Director: Françoise LAZARINI, PhD Institut Pasteur, Paris France
PRS Account Institut Pasteur
Verification Date August 2018