Esophageal AtresiaREGATENCT02883725
National Register of Oesophageal Atresia
An observational study of Esophageal Atresia, run by University Hospital, Lille at 37 sites in 3 countries.
Trial summary
The esophageal atresia is a group of birth defects including a break in continuity of the esophagus with or without persistent communication with the trachea (tracheoesophageal fistula), sometimes associated (from 50%) of other malformations (heart, kidney, digestive ...). Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Esophageal Atresia
- What is being tested?
- data collection
- How many people
- 1,460 participants
- Where
- 37 sitesin 3 countries
- Study dates
- 1 Jan 2008to 31 Dec 2019
- 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 Up to 1 year
- All sexes
- No healthy volunteers
- Child
Study population: All living newborns having a esophageal atresia supported in a neonatal unit, neonatal intensive care and pediatric surgery of France
Who may be able to join
- To be born in France
- To have a esophageal atresia
Who cannot join
- To be born abroad
Trial locations and contacts
37 sites in 3 countries.
37 sites in 3 countries
France35 sites
CHU Amiens-Picardie
Amiens
CHU d'Angers
Angers
CHRU Besançon
Besançon
CHU de Bordeaux
Bordeaux
CHRU Brest
Brest
HFME de Lyon
Bron
CHU de Caen
Caen
CHU de Clermont-Ferrand
Clermont-Ferrand
Hôpitaux Civils de Colmar
Colmar
CHI Créteil
Créteil
CHU Dijon Bourgogne
Dijon
CHU de Grenoble
La Tronche
AP-HP CHU Kremlin-Bicêtre
Le Kremlin-Bicêtre
CH Le Mans
Le Mans
CHRU,Hôpital Jeanne de Flandres
Lille
CHU de Limoges
Limoges
AP-HM La Timone
Marseille
AP-HM Nord
Marseille
CHRU de Montpellier
Montpellier
CHU de Nantes
Nantes
CHU de Nice
Nice
CHR d'Orléans
Orléans
AP-HP Armand Trousseau
Paris
AP-HP Necker-Enfants malades
Paris
AP-HP Robert-Debré
Paris
CHU de Poitiers
Poitiers
CHU de Reims
Reims
CHU de Rennes
Rennes
CHU de Rouen
Rouen
CHU Félix-Guyon
Saint-Denis, La Réunion
CHU de Saint-Etienne
Saint-Priest-en-Jarez
CHU de Strasbourg
Strasbourg
CHU de Toulouse
Toulouse
CHRU de Tours
Tours
CHU de Nancy
Vandœuvre-lès-Nancy
About this study
The esophageal atresia is a group of birth defects including a break in continuity of the esophagus with or without persistent communication with the trachea (tracheoesophageal fistula), sometimes associated (from 50%) of other malformations (heart, kidney, digestive ...).
The current prognosis for this ailment is good. However he persists a mortality (<10%) and significant morbidity, firstly related malformations (heart, kidney, for example), and secondly with particularly difficult anatomical forms (Forms long defect) .
Read more
The prevalence of this condition is estimated to be 1/2500 in 3000 live births, making an estimated ± 2,500 new cases over to 10 years in France.
The current project aims to set up a national registry (Metropolitan France and Dom Tom) to measure the prevalence of esophageal atresia among live births, phenotypic characteristics, the circumstances of their diagnosis, and their initial future at short-term during the first year of life, at which time occurs the vast majority of deaths and complications in this disease.
- Conditions
- Esophageal Atresia
- Being tested
- data collection
- Keywords
- Esophageal atresia
- Medical subject headings
- Esophageal Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
| Study group | Role | What they receive |
|---|---|---|
| Esophageal atresia | Not described Receives: Other: data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of esophageal atresia
Measured: 10 years
Secondary outcomes (3)
Data collection patient with esophageal atresia
Circumstances of diagnosis, modalities of follow-up and clinical management
Measured: 10 years
Total number of patients with complications
Measured: 10 years
Death
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study start1 Jan 2008
- Primary completion31 Dec 2016
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal AtresiaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,460 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric Gottrand, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883725
- Sponsor's protocol ID
- Reg 2008
- Other IDs
- 908362, 08.297
- Acronym
- REGATE
- Status last verified
- Apr 2026
- First submitted
- 18 Aug 2016
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lejeune S, Sfeir R, Rousseau V, Bonnard A, Gelas T, Aumar M, Panait N, Rabattu PY, Irtan S, Fouquet V, Le Mandat A, Cocci SN, Habonimana E, Lamireau T, Lemelle JL, Elbaz F, Talon I, Boudaoud N, Allal H, Buisson P, Petit T, Sapin E, Lardy H, Schmitt F, Levard G, Scalabre A, Michel JL, Jaby O, Pelatan C, De Vries P, Borderon C, Fourcade L, Breaud J, Arnould M, Tolg C, Chaussy Y, Geiss S, Laplace C, Drumez E, El Mourad S, Thumerelle C, Gottrand F. Esophageal Atresia and Respiratory Morbidity. Pediatrics. 2021 Sep;148(3):e2020049778. doi: 10.1542/peds.2020-049778. Epub 2021 Aug 19.
PubMed 34413249
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Register of Oesophageal Atresia
- ClinicalTrials.gov ID
- NCT02883725
- Acronym / sponsor ID
- REGATE / Reg 2008
- Conditions
- Esophageal Atresia
- Keywords
- Esophageal atresia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,460 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 30 Aug 2016 (estimated)
- 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.
The esophageal atresia is a group of birth defects including a break in continuity of the esophagus with or without persistent communication with the trachea (tracheoesophageal fistula), sometimes associated (from 50%) of other malformations (heart, kidney, digestive ...).
The current prognosis for this ailment is good. However he persists a mortality (<10%) and significant morbidity, firstly related malformations (heart, kidney, for example), and secondly with particularly difficult anatomical forms (Forms long defect) .
The prevalence of this condition is estimated to be 1/2500 in 3000 live births, making an estimated ± 2,500 new cases over to 10 years in France.
The current project aims to set up a national registry (Metropolitan France and Dom Tom) to measure the prevalence of esophageal atresia among live births, phenotypic characteristics, the circumstances of their diagnosis, and their initial future at short-term during the first year of life, at which time occurs the vast majority of deaths and complications in this disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Esophageal atresia | – | Other: data collection |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All living newborns having a esophageal atresia supported in a neonatal unit, neonatal intensive care and pediatric surgery of France
Key inclusion criteria (2 listed)
- To be born in France
- To have a esophageal atresia
Key exclusion criteria (1 listed)
- To be born abroad
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 |
|---|---|---|
| data collection | Other | Esophageal atresia |
Primary outcome
Number of esophageal atresia
Time frame: 10 years
3 secondary outcomes
Data collection patient with esophageal atresia
Time frame: 10 years
Total number of patients with complications
Time frame: 10 years
Death
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Results publication: PubMed 34413249Lejeune S, Sfeir R, Rousseau V, Bonnard A, Gelas T, Aumar M, Panait N, Rabattu PY, Irtan S, Fouquet V, Le Mandat A, Cocci SN, Habonimana E, Lamireau T, Lemelle JL, Elbaz F, Talon I, Boudaoud N, Allal H, Buisson P, Petit T, Sapin E, Lardy H, Schmitt F, Levard G, Scalabre A, Michel JL, Jaby O, Pelatan C, De Vries P, Borderon C, Fourcade L, Breaud J, Arnould M, Tolg C, Chaussy Y, Geiss S, Laplace C, Drumez E, El Mourad S, Thumerelle C, Gottrand F. Esophageal Atresia and Respiratory Morbidity. Pediatrics. 2021 Sep;148(3):e2020049778. doi: 10.1542/peds.2020-049778. Epub 2021 Aug 19.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Frédéric Gottrand, MD, PhD principal investigator
University Hospital, Lille
37 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Atresia, run by University Hospital, Lille at 37 sites in 3 countries.
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 2 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: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in France, Guadeloupe, Martinique. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of esophageal atresia (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02883725, which also lists 1 linked publication.
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 5 May 2026.