ITMO public health
Last update : 09/05/2017 | Version : 3 | ID : 5664
| General | |
| Identification | |
| Detailed name | Newborn screening for congenital hypothyroidism - Development of young adults treated for congenital hypothyroidism since neonatal period: health, fertility, pregnancy outcomes and children's health |
| Sign or acronym | CONGENITAL HYPOTHYROIDISM |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Accord CNIL n°906178 (31/07/2006) |
| General Aspects | |
| Medical area |
Endocrinology and metabolism |
| Health determinants |
Genetic |
| Keywords | vital status, socio-professional insertion, fertility, children, Health episodes, treatment, quality of life, morbidity, pregnancy, environment |
| Scientific investigator(s) (Contact) | |
| Name of the director | Leger |
| Surname | Juliane |
| Address |
48 boulevard Sérurier 75935 Paris Cedex 19 |
| Phone | + 33 (0)1 40 03 23 54 |
| juliane.leger@rdb.aphp.fr | |
| Unit | CENTRE DE RÉFÉRENCE MALADIES ENDOCRINIENNES RARES DE LA CROISSANCE HÔPITAL ROBERT DEBRÉ AP-HP |
| Organization | AP-HP |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | PHRC 2005, Fondation WYETH |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Hôpital Robert Debré |
| 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 carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Prospective Inclusion cut-off date: 01/12/1988 |
| Database objective | |
| Main objective | General objective: To analyse the development into adulthood for individuals treated for congenital hypothyroidism (CH) since neonatal period, thanks to routine screening established in France since 1978. Secondary objectives: - to assess health at adult age, quality of life and socio-professional insertion and fertility as well as children's health i.e. children of subjects treated for CH. To research thyroid developmental anomaly and general development during first year of life. - to identify sub-groups of candidate patients according to phenotype for genetic study. The analysis of pregnancy progress and outcome as well as thyroxine requirements during pregnancy is included in the study of women treated for CH. - To improve treatment strategies (children, adolescents, adults, pregnant women). |
| Inclusion criteria | Hypothyroidsm detected during neonatal period between 1978 and 1988 |
| 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) Adolescence (13 to 18 years) Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Gender |
Woman |
| Geography area |
National |
| Detail of the geography area | Multicentric cohort throughout metropolitan France (20 centres): |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 01/1978 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1804 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Declarative data |
| Declarative data (detail) |
Paper self-questionnaire |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Quality of life/health perception |
| Procedures | |
| Data collection method | Self-administered questionnaire: manual input |
| Participant monitoring |
Yes |
| Details on monitoring of participants | (Indefinite duration) |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | RNIAM (JO 11 JUNE 20007) French association for the detection and prevention of childhood disabilities |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/Pubmed-HYPOTHYROIDIE |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | To be decided if data may be used by academic teams Data may not be used by industrial teams |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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