National Register of Oesophageal Atresia (REGATE)

May 17, 2022 updated by: University Hospital, Lille

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Amiens, France
        • Recruiting
        • CHU Amiens-Picardie
      • Angers, France
        • Recruiting
        • CHU d'Angers
      • Besançon, France
        • Recruiting
        • CHRU Besançon
      • Bordeaux, France
        • Recruiting
        • CHU de Bordeaux
      • Brest, France
        • Recruiting
        • CHRU Brest
      • Bron, France
        • Recruiting
        • HFME de Lyon
      • Caen, France
        • Recruiting
        • CHU de Caen
      • Clermont-Ferrand, France
        • Recruiting
        • CHU de Clermont-Ferrand
      • Colmar, France
        • Recruiting
        • Hopitaux Civils de Colmar
      • Créteil, France
        • Recruiting
        • CHI Créteil
      • Dijon, France
        • Recruiting
        • CHU Dijon Bourgogne
      • La Tronche, France
        • Recruiting
        • CHU de Grenoble
      • Le Kremlin-Bicêtre, France
        • Recruiting
        • AP-HP CHU Kremlin-Bicêtre
      • Le Mans, France
        • Recruiting
        • CH Le Mans
      • Lille, France
        • Recruiting
        • CHRU,Hôpital Jeanne de Flandres
        • Sub-Investigator:
          • Rony Sfeir, MD
      • Limoges, France
        • Recruiting
        • CHU de Limoges
      • Marseille, France
        • Recruiting
        • AP-HM La Timone
      • Marseille, France
        • Recruiting
        • AP-HM Nord
      • Montpellier, France
        • Recruiting
        • CHRU de Montpellier
      • Nantes, France
        • Recruiting
        • CHU de Nantes
      • Nice, France
        • Recruiting
        • CHU de Nice
      • Orléans, France
        • Recruiting
        • CHR d'Orléans
      • Paris, France
        • Recruiting
        • AP-HP Armand Trousseau
      • Paris, France
        • Recruiting
        • AP-HP Necker-Enfants malades
      • Paris, France
        • Recruiting
        • AP-HP Robert-Debré
      • Poitiers, France
        • Recruiting
        • CHU De Poitiers
      • Reims, France
        • Recruiting
        • CHU de Reims
      • Rennes, France
        • Recruiting
        • CHU de Rennes
      • Rouen, France
        • Recruiting
        • CHU de Rouen
      • Saint-Priest en Jarez, France
        • Recruiting
        • CHU DE SAINT-ETIENNE
      • Strasbourg, France
        • Recruiting
        • CHU de Strasbourg
      • Toulouse, France
        • Recruiting
        • CHU de Toulouse
      • Tours, France
        • Recruiting
        • CHRU De Tours
      • Vandœuvre-lès-Nancy, France
        • Recruiting
        • Chu de Nancy
    • La Réunion
      • Saint Denis, La Réunion, France
        • Recruiting
        • CHU Félix-Guyon
  • Guadeloupe
      • Pointe-à-Pitre, Guadeloupe
        • Recruiting
        • CHU de Pointe-à-Pitre
  • Martinique
      • Fort-de-France, Martinique, 97200
        • Recruiting
        • CHU de Martinique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All living newborns having a esophageal atresia supported in a neonatal unit, neonatal intensive care and pediatric surgery of France

Description

Inclusion Criteria:

  • To be born in France
  • To have a esophageal atresia

Exclusion Criteria:

  • To be born abroad

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Esophageal atresia
Other: data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of esophageal atresia
Time Frame: 10 years
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: 10 years
10 years
Data collection patient with esophageal atresia
Time Frame: 10 years
Circumstances of diagnosis, modalities of follow-up and clinical management
10 years
Total number of patients with complications
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2008

Primary Completion (ANTICIPATED)

December 1, 2025

Study Completion (ANTICIPATED)

December 1, 2025

Study Registration Dates

First Submitted

August 18, 2016

First Submitted That Met QC Criteria

August 24, 2016

First Posted (ESTIMATE)

August 30, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 18, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Reg 2008
  • 908362 (OTHER: CNIL number)
  • 08.297 (OTHER: CCTIRS number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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