OMA - Evaluation of the management of acute otitis media in children aged ≤ 6 years in France 
Head :
Leclerc-Zwirn Christel, Laboratoire GSK
Last update : 01/01/2019 | Version : 1 | ID : 157
| General | |
| Identification | |
| Detailed name | Evaluation of the management of acute otitis media in children aged ≤ 6 years in France |
| Sign or acronym | OMA |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL : 770 334 |
| General Aspects | |
| Medical area |
Infectious diseases |
| Others (details) | Acute otitis media |
| Keywords | epidemiology, care |
| Scientific investigator(s) (Contact) | |
| Name of the director | Leclerc-Zwirn |
| Surname | Christel |
| Phone | +33 (0)1 39 17 86 96 |
| christel.c.leclerc-zwirn@gsk.com | |
| Unit | Laboratoire GSK |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | GSK laboratory |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Laboratoire GSK |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Longitudinal study (except cohorts) |
| Database recruitment is carried out by an intermediary |
A selection of health care professionals A selection of health institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. |
Sending of an email presenting the study to all GPs and pediatricians in the Thalès network offering them to participate in the study. The Thalès network to date has 1,200 general practitioners and 100 pediatricians. • Doctors interested in the study can identify themselves on the Internet website and confirm their participation agreement. A random drawing will then be done to recruit the necessary number of participating doctors. • 1st phase: For a period of 15 days, the first children (3 on the average) consulting for an episode of AOM will be included in the study and will be followed. |
| Database objective | |
| Main objective | Describe in general practice the care for AOM in children aged 0 to 6 years in France. |
| Inclusion criteria |
• Child aged 0 to 6 years • Child with an episode of AOM diagnosed by a doctor • Parent(s)/tutor(s) who accept the inclusion of the child in the study |
| Population type | |
| Age |
Newborns (birth to 28 days) Infant (28 days to 2 years) Early childhood (2 to 5 years) Childhood (6 to 13 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2008 |
| Date of last collection (YYYY or MM/YYYY) | 2009 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 439 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Paper self-questionnaire |
| Presence of a biobank |
No |
| Health parameters studied |
Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | Medical questionnaire, parent questionnaire, follow-up questionnaire |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Each child will be followed for 2 weeks (medical follow-up questionnaire and parent questionnaire). In the case of a relapse appearing in the week following the AOM episode, a follow-up questionnaire will be completed. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Publications in progress |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
