Birth Defect Registry in South West Region of France (ATENA)

Registry of Congenital Anomalies in Nouvelle-Aquitaine, France

Regional population-based registry for the epidemiological surveillance of congenital anomalies

Study Overview

• Status: Not yet recruiting
• Conditions: Congenital Abnormalities
• Intervention / Treatment: Other: Environmental survey

Detailed Description

By systematically collecting data on congenital anomalies, the registry aims to :

• provide essential epidemiological information on congenital anomalies in South West of France
• Promote etiological research concerning congenital anomalies, particularly with regard to environmental risk factors (systematic questionnaire) and other teratogenic agents (drugs)
• act as an information and resource center for the population, health professionals and managers regarding clusters or exposures or risk factors of concern.
• evaluate the effectiveness of primary prevention
• assess the impact of developments in prenatal screening
• study the fate of children with congenital anomalies, particularly in terms of neurodevelopment, through the creation of cohorts.

• Study Type: Observational
• Enrollment (Anticipated): 9000

Contacts and Locations

• Study Contact: Name: Julie Thomas-Chabaneix, MD; Phone Number: +33 (0)5 57 65 61 10; Email: julie.thomas@chu-bordeaux.fr
• Study Contact Backup: Name: Anne-Cécile Huby; Email: anne-cecile.huby@chu-bordeaux.fr

Study Locations

• France
  • Pessac, France, 33604
    • Bordeaux University Hospital
    • Contact: Julie Thomas-Chabaneix, MD; Phone Number: +33 (0)5 57 65 61 10; Email: julie.thomas@chu-bordeaux.fr
    • Contact: Anne-Cécile Huby; Email: anne-cecile.huby@chu-bordeaux.fr
    • Sub-Investigator: Caroline Rooryck-Thambo, MD PhD
    • Sub-Investigator: Marianne Saves, MD PhD
    • Sub-Investigator: Fleur Delva, MD PhD
    • Sub-Investigator: Romain Griffier, MD
    • Sub-Investigator: Florence Francis, MD
    • Principal Investigator: Julie Thomas-Chabaneix, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 4 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cases are defined as all fetuses/children under 1 year of age with a congenital or chromosomal abnormality as defined by the european surveillance of congenital anomalies (EUROCAT) network.

The excluded minor anomalies are established by EUROCAT. The register covers the geographical area of the Nouvelle Aquitaine region in France.

Description

Inclusion Criteria:

Children or Fetuses:

• Born alive or stillborn or fetal death in utero or medical termination of pregnancy
• Of mothers domiciled in New Aquitaine at the time of delivery
• And presenting a congenital or chromosomal anomaly defined according to the EUROCAT network, diagnosed antenatally or postnatally up to one year of life.
• Of which the non-opposition of both holders or of the only holder of parental authority has been given
• Whose mother and/or father is affiliated or beneficiary of a social security system.

Exclusion Criteria:

• Refusal of at least one of the holders of parental authority

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of congenital anomalies	1 year-old

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of the incidence of congenital anomalies in south west region of France	In number of new cases, expected 2500 cases/year	1 year-old
Identification of environmental factors associated with congenital anomalies	Environment related variables and drug exposure before (father and mother) and during pregnancy (mother)	1 year-old

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; Institut de Recherche en Santé Publique, France
• Investigators: Principal Investigator: Julie Thomas-Chabaneix, MD, University Hospital, Bordeaux; Study Chair: Marianne Saves, MD, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): March 1, 2025
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: January 28, 2022
• First Posted (Actual): February 9, 2022

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: February 21, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: CHUBX 2019/36

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No