Congenital AbnormalitiesATENANCT05231447
Birth Defect Registry in South West Region of France
An observational study of Congenital Abnormalities, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Regional population-based registry for the epidemiological surveillance of congenital anomalies Read more about this study
- Who is it for?
- Ages 1 minute to 1 year
- Conditions the study is for
- Congenital Abnormalities
- What is being tested?
- Environmental survey
- How many people
- 9,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2022to 1 Mar 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 1 year
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Refusal of at least one of the holders of parental authority
Trial locations and contacts
1 site in 1 country.
Anne-Cécile Huby contact
France1 site
Bordeaux University Hospital
Pessac, 33604
Julie Thomas-Chabaneix, MD, (0)5 57 65 61 10 ext. +33, julie.thomas@chu-bordeaux.fr
Anne-Cécile Huby, anne-cecile.huby@chu-bordeaux.fr
About this study
Official title: Registry of Congenital Anomalies in Nouvelle-Aquitaine, France
Regional population-based registry for the epidemiological surveillance of congenital anomalies
Read the 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.
- Conditions
- Congenital Abnormalities
- Being tested
- Environmental survey
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Environmental surveyOther
Exposure to environmental factors, drugs or individual toxicity during the periconceptional period and at the beginning of the pregnancy will be investigated by means of a questionnaire administered to the parents. This questionnaire, drawn up by the "Aquitaine Reproduction Enfance Maternité et Impact Santé-environnement" (ARTEMIS) centre and completed by both members of the couple, will constitute an initial assessment that will make it possible to collect environmental exposures for the parents of cases identified by the register.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of congenital anomalies
Measured: 1 year-old
Secondary outcomes (2)
Measure of the incidence of congenital anomalies in south west region of France
In number of new cases, expected 2500 cases/year
Measured: 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)
Measured: 1 year-old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start1 Mar 2022 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital AbnormalitiesStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 9,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recherche en Santé Publique, France, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- Julie Thomas-Chabaneix, MD, Principal investigator, University Hospital, BordeauxMarianne Saves, MD, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231447
- Sponsor's protocol ID
- CHUBX 2019/36
- Acronym
- ATENA
- Status last verified
- Feb 2022
- First submitted
- 28 Jan 2022
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Congenital Anomalies in Nouvelle-Aquitaine, France
- ClinicalTrials.gov ID
- NCT05231447
- Acronym / sponsor ID
- ATENA / CHUBX 2019/36
- Conditions
- Congenital Abnormalities
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 9,000 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Institut de Recherche en Santé Publique, France, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Regional population-based registry for the epidemiological surveillance of congenital anomalies
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 1 minute to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- Refusal of at least one of the holders of parental authority
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Environmental surveyExposure to environmental factors, drugs or individual toxicity during the periconceptional period and at the beginning of the pregnancy will be investigated by means of a questionnaire administered to the parents. This questionnaire, drawn up by the "Aquitaine Reproduction Enfance Maternité et Impact Santé-environnement" (ARTEMIS) centre and completed by both members of the couple, will constitute an initial assessment that will make it possible to collect environmental exposures for the parents of cases identified by the register. | Other | – |
Primary outcome
Number of congenital anomalies
Time frame: 1 year-old
2 secondary outcomes
Measure of the incidence of congenital anomalies in south west region of France
Time frame: 1 year-old
Identification of environmental factors associated with congenital anomalies
Time frame: 1 year-old
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Cécile Huby contact
Julie Thomas-Chabaneix, MD principal investigator
University Hospital, Bordeaux
Marianne Saves, MD study chair
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Abnormalities, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie Thomas-Chabaneix, MD ((0)5 57 65 61 10 ext. +33, julie.thomas@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of congenital anomalies (time frame: 1 year-old). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.