Last update : 07/06/2014 | Version : 1 | ID : 60195
| General | |
| Identification | |
| Detailed name | Asthma newborn cohort/Exhaled Nitric Oxide as a Predictive Marker for Asthma? |
| Sign or acronym | NOA |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL : 04/05/2009 |
| General Aspects | |
| Medical area |
Pneumology Study of allergies |
| Others (details) | Asthma |
| Keywords | prognosis, paediatrics, Morbidity, mortality, genetic factors, diagnosis |
| Scientific investigator(s) (Contact) | |
| Name of the director | Just |
| Surname | Jocelyne |
| Address | 75012 PARIS |
| Phone | +33 (0)1 44 73 68 47 |
| jocelyne.just@trs.aphp.fr | |
| Unit | CENTRE DE L'ASTHME ET DES ALLERGIES EA 4064 SANTÉ PUBLIQUE ET ENVIRONNEMENT APHP, UNIVERSITÉ PARIS 6 |
| Name of the director | Momas |
| Surname | Isabelle |
| Address | 75005 PARIS |
| Phone | +33 (0)1 43 73 97 31 |
| isabelle.momas@univ-paris5.fr | |
| Unit | EA 4064 SANTÉ PUBLIQUE ET ENVIRONNEMENT UNIVERSITÉ PARIS 5 |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | Association poumon et enfance Société de pneumologie de langue française Divers laboratoires pharmaceutiques |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | APHP |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| 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: 01/01/2011 |
| Database objective | |
| Main objective | To show that an increase in eNO, a biomarker of airway inflammation, is a risk factor expected from passage of recurrent wheezing in infancy towards childhood asthma at pre-school age (age 4 to 7 years old). Secondary objectives: - To assemble an international cohort of patients selected from homogeneous criteria established by a panel of experts. - To allow a homogeneous collection of retrospective and prospective data on childhood BD in real-time thanks to the creation of an on-line database. - To support genetic studies and conduct a parallel collection of DNA. |
| Inclusion criteria |
- less than 30 monhts - asthma or Allergic Rhinitis |
| Population type | |
| Age |
Newborns (birth to 28 days) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
Regional |
| French regions covered by the database |
Île-de-France |
| Detail of the geography area | Paris and surrounding region |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 01/2010 |
| Date of last collection (YYYY or MM/YYYY) | 01/2014 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 315 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Declarative data Biological data |
| Declarative data (detail) |
Paper self-questionnaire Face to face interview |
| Biological data (detail) | DNA, cells |
| Presence of a biobank |
Yes |
| Contents of biobank |
Serum DNA |
| Details of biobank content | Serum bank, DNA bank |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | Interviews: manual input from a paper questionnaire Biological analysis: handwritten |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Duration: 3 years |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Data may not be used by academic or industrial teams. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
No access |
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