Clinical trial NCT02883725: National Register of Oesophageal Atresia
Official title: National Register of Oesophageal Atresia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Atresia
Keywords: Esophageal atresia
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 2500
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* To be born abroad

Primary outcomes:
measure: Number of esophageal atresia
timeFrame: 10 years
Secondary outcomes:
measure: Data collection patient with esophageal atresia
timeFrame: 10 years
measure: Total number of patients with complications
timeFrame: 10 years
measure: Death
timeFrame: 10 years
Other outcomes:
Locations:
city: Saint Denis
country: France
facility: CHU Félix-Guyon
state: La Réunion
city: Amiens
country: France
facility: CHU Amiens-Picardie
city: Angers
country: France
facility: CHU d'Angers
city: Besançon
country: France
facility: CHRU Besançon
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Brest
country: France
facility: CHRU Brest
city: Bron
country: France
facility: HFME de Lyon
city: Caen
country: France
facility: CHU de Caen
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Colmar
country: France
facility: Hôpitaux Civils de Colmar
city: Créteil
country: France
facility: CHI Créteil
city: Dijon
country: France
facility: CHU Dijon Bourgogne
city: La Tronche
country: France
facility: CHU de Grenoble
city: Le Kremlin-Bicêtre
country: France
facility: AP-HP CHU Kremlin-Bicêtre
city: Le Mans
country: France
facility: CH Le Mans
city: Lille
country: France
facility: CHRU,Hôpital Jeanne de Flandres
city: Limoges
country: France
facility: CHU de Limoges
city: Marseille
country: France
facility: AP-HM La Timone
city: Marseille
country: France
facility: AP-HM Nord
city: Montpellier
country: France
facility: CHRU de Montpellier
city: Nantes
country: France
facility: CHU de Nantes
city: Nice
country: France
facility: CHU de Nice
city: Orléans
country: France
facility: CHR d'Orléans
city: Paris
country: France
facility: AP-HP Armand Trousseau
city: Paris
country: France
facility: AP-HP Necker-Enfants malades
city: Paris
country: France
facility: AP-HP Robert-Debré
city: Poitiers
country: France
facility: CHU de Poitiers
city: Reims
country: France
facility: CHU de Reims
city: Rennes
country: France
facility: CHU de Rennes
city: Rouen
country: France
facility: CHU de Rouen
city: Saint-Priest en Jarez
country: France
facility: CHU de Saint-Etienne
city: Strasbourg
country: France
facility: CHU de Strasbourg
city: Toulouse
country: France
facility: CHU de Toulouse
city: Tours
country: France
facility: CHRU de Tours
city: Vandœuvre-lès-Nancy
country: France
facility: CHU de Nancy
city: Pointe-à-Pitre
country: Guadeloupe
facility: CHU de Pointe-à-Pitre
city: Fort-de-France
country: Martinique
facility: CHU de Martinique
Study officials:
affiliation: University Hospital, Lille
name: Frédéric Gottrand, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.