NCT02883725

Brief 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 ...). 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,460

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
3 countries

37 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
8.6 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

9 years

First QC Date

August 18, 2016

Last Update Submit

April 29, 2026

Conditions

Keywords

Esophageal atresia

Outcome Measures

Primary Outcomes (1)

  • Number of esophageal atresia

    10 years

Secondary Outcomes (3)

  • Data collection patient with esophageal atresia

    10 years

  • Total number of patients with complications

    10 years

  • Death

    10 years

Study Arms (1)

Esophageal atresia

Other: data collection

Interventions

Esophageal atresia

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • To be born abroad

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (37)

CHU Félix-Guyon

Saint-Denis, La Réunion, France

Location

CHU Amiens-Picardie

Amiens, France

Location

CHU d'Angers

Angers, France

Location

CHRU Besançon

Besançon, France

Location

CHU de Bordeaux

Bordeaux, France

Location

CHRU Brest

Brest, France

Location

HFME de Lyon

Bron, France

Location

CHU de Caen

Caen, France

Location

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Location

Hôpitaux Civils de Colmar

Colmar, France

Location

CHI Créteil

Créteil, France

Location

CHU Dijon Bourgogne

Dijon, France

Location

CHU de Grenoble

La Tronche, France

Location

AP-HP CHU Kremlin-Bicêtre

Le Kremlin-Bicêtre, France

Location

CH Le Mans

Le Mans, France

Location

CHRU,Hôpital Jeanne de Flandres

Lille, France

Location

CHU de Limoges

Limoges, France

Location

AP-HM La Timone

Marseille, France

Location

AP-HM Nord

Marseille, France

Location

CHRU de Montpellier

Montpellier, France

Location

CHU de Nantes

Nantes, France

Location

CHU de Nice

Nice, France

Location

CHR d'Orléans

Orléans, France

Location

AP-HP Armand Trousseau

Paris, France

Location

AP-HP Necker-Enfants malades

Paris, France

Location

AP-HP Robert-Debré

Paris, France

Location

CHU de Poitiers

Poitiers, France

Location

CHU de Reims

Reims, France

Location

CHU de Rennes

Rennes, France

Location

CHU de Rouen

Rouen, France

Location

CHU de Saint-Etienne

Saint-Priest-en-Jarez, France

Location

CHU de Strasbourg

Strasbourg, France

Location

CHU de Toulouse

Toulouse, France

Location

CHRU de Tours

Tours, France

Location

CHU de Nancy

Vandœuvre-lès-Nancy, France

Location

CHU de Pointe-à-Pitre

Pointe-à-Pitre, Guadeloupe

Location

CHU de Martinique

Fort-de-France, 97200, Martinique

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Esophageal Atresia

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Digestive System AbnormalitiesDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Frédéric Gottrand, MD, PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2016

First Posted

August 30, 2016

Study Start

January 1, 2008

Primary Completion

December 31, 2016

Study Completion

December 31, 2019

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations