Congenital Cytomegalovirus InfectionINFECSMELLNCT02782988
Assesment of Olfactory Disorders and Performance of a New Olfactory Test in Children With Congenital CMV
An observational study of Congenital Cytomegalovirus Infection, run by Institut Pasteur at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Cytomegalovirus Infection
- What is being tested?
- olfactory tests, otoacoustic emissions (OAE)
- How many people
- 106 participants
- Where
- 2 sitesFrance
- Study dates
- May 2016to 2 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hopital Bicêtre
Le Kremlin-Bicêtre, 94270
Robert Debré Hospital
Paris, 75019
About this study
Official title: Assesment of Olfactory Disorders and Performance of a New Olfactory Test in Children With Congenital Cytomegalovirus Infection
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.
Read the 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.
- Conditions
- Congenital Cytomegalovirus Infection
- Being tested
- olfactory tests, otoacoustic emissions (OAE)
- Keywords
- Olfaction, CMV
- Medical subject headings
- Cytomegalovirus Infections, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olfactory tests, otoacoustic emissions (OAE)Other
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 group | Role | What they receive |
|---|---|---|
| CMV symptomatic at birth | olfactory tests, otoacoustic emissions (OAE) Receives: Other: olfactory tests, otoacoustic emissions (OAE) | |
| CMV asymptomatic at birth | olfactory tests, otoacoustic emissions (OAE) Receives: Other: olfactory tests, otoacoustic emissions (OAE) | |
| Healthy controls | olfactory tests, otoacoustic emissions (OAE) Receives: Other: olfactory tests, otoacoustic emissions (OAE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of children with olfactory disorders among children with congenital CMV infection.
Measured: Inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study startMay 2016
- Primary completion2 May 2020
- Study completion2 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Cytomegalovirus InfectionStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Françoise LAZARINI, PhD, Study director, Institut Pasteur, Paris France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782988
- Sponsor's protocol ID
- 2015-091
- Acronym
- INFECSMELL
- Status last verified
- Jul 2021
- First submitted
- 23 May 2016
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assesment of Olfactory Disorders and Performance of a New Olfactory Test in Children With Congenital Cytomegalovirus Infection
- ClinicalTrials.gov ID
- NCT02782988
- Acronym / sponsor ID
- INFECSMELL / 2015-091
- Conditions
- Congenital Cytomegalovirus Infection
- Keywords
- Olfaction, CMV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- 2 May 2020 (actual)
- Study completion
- 2 May 2020 (actual)
- First posted
- 26 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CMV symptomatic at birth | – | Other: olfactory tests, otoacoustic emissions (OAE)olfactory tests, otoacoustic emissions (OAE) |
| CMV asymptomatic at birth | – | Other: olfactory tests, otoacoustic emissions (OAE)olfactory tests, otoacoustic emissions (OAE) |
| Healthy controls | – | Other: olfactory tests, otoacoustic emissions (OAE)olfactory tests, otoacoustic emissions (OAE) |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | CMV asymptomatic at birth, CMV symptomatic at birth, Healthy controls |
Primary outcome
Percentage of children with olfactory disorders among children with congenital CMV infection.
Time frame: Inclusion visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Françoise LAZARINI, PhD study director
Institut Pasteur, Paris France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Cytomegalovirus Infection, run by Institut Pasteur at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of children with olfactory disorders among children with congenital CMV infection. (time frame: Inclusion visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.