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

NCT02782988 | Completed

• 1 other identifier: 2015-091
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 2

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.

Conditions

Congenital Cytomegalovirus Infection

Keywords

Olfaction; CMV

Outcome Measures

Primary Outcomes (1)

• Percentage of children with olfactory disorders among children with congenital CMV infection.

  Inclusion visit

Study Arms (3)

CMV symptomatic at birth

olfactory tests, otoacoustic emissions (OAE)

Other: olfactory tests, otoacoustic emissions (OAE)

CMV asymptomatic at birth

olfactory tests, otoacoustic emissions (OAE)

Other: olfactory tests, otoacoustic emissions (OAE)

Healthy controls

olfactory tests, otoacoustic emissions (OAE)

Other: olfactory tests, otoacoustic emissions (OAE)

Interventions

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.

CMV asymptomatic at birth; CMV symptomatic at birth; Healthy controls

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Pasteur: lead

Study Sites (2)

Hopital Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

Robert Debré Hospital

Paris, 75019, France

Location

MeSH Terms

Conditions

Cytomegalovirus Infections; Anosmia

Interventions

Otoacoustic Emissions, Spontaneous

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hearing; Vestibulocochlear Physiological Phenomena; Physiological Phenomena; Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Françoise LAZARINI, PhD

  Institut Pasteur, Paris France

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: May 26, 2016
• Study Start: May 1, 2016
• Primary Completion: May 2, 2020
• Study Completion: May 2, 2020
• Last Updated: July 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)