ITMO public health
Last update : 01/01/2020 | Version : 1 | ID : 73284
| General | |
| Identification | |
| Detailed name | Longitudinal study of newborns: screening, prevalence and treatment of deafness |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL |
| General Aspects | |
| Medical area |
Otolaryngology or ENT |
| Pathology (details) | Hearing loss |
| Health determinants |
Healthcare system and access to health care services |
| Keywords | Hearing loss, Screening, Child, treatment, prevalence |
| Scientific investigator(s) (Contact) | |
| Name of the director | Rouillon |
| Surname | Isabelle |
| Phone | +33 (0)1 71 39 67 94 |
| isabelle.rouillon@nck.aphp.fr | |
| Organization | hôpital Necker – Enfants-Malades |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | CNAMTS |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | hôpital Necker – Enfants-Malades |
| Organisation status |
Public |
| 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 institutions and services |
| Database recruitment is is made on the basis of: |
Another treatment or procedure |
| Database recruitment is carried out as part of an interventional study |
No |
| Database objective | |
| Main objective | Evaluate hearing screening for newborns born in the Ile-de-France region |
| Inclusion criteria |
Screening conducted in four maternity clinics between 1 October 2005 and 31 December 2010, in conjunction with a Deafness Diagnosis and Guidance Centre (CDOS)
Positive screening in maternity clinics: lack of response to automated auditory evoked potential of 35 dB on both sides For diagnostic confirmation: no response to standard auditory evoked potential of 30 dB at the CDOS |
| Population type | |
| Age |
Newborns (birth to 28 days) Infant (28 days to 2 years) |
| Population covered |
General population |
| Pathology | |
| Gender |
Male Woman |
| Geography area |
Regional |
| French regions covered by the database |
Île-de-France |
| Detail of the geography area | the CDOS (Hôpital Trousseau) where the study was carried out is networked with 4 maternity clinics in the Ile-de-France region |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2005 |
| Date of last collection (YYYY or MM/YYYY) | 2010 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 198 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data |
| Clinical data (detail) |
Medical registration |
| Details of collected clinical data | Risk factors and comorbidities, 1st diagnosis period and result. The type of loss and rehabilitation (hearing aid, cochlear implant) and duration of treatment. Audiometric results, results of the aetiological assessment |
| Presence of a biobank |
No |
| Health parameters studied |
Health care consumption and services |
| Care consumption (detail) |
Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Participant monitoring |
Yes |
| Monitoring procedures |
Monitoring by convocation of the participant |
| Details on monitoring of participants | 15-month follow-up |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/26520479 |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | unrestricted provision |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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