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NCT02883725 Clinical Trial

National Register of Oesophageal Atresia

Esophageal Atresia Clinical Trial

— REGATE  

Official title:
National Register of Oesophageal Atresia

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02883725
Other study ID # Reg 2008
Secondary ID 90836208.297
Status Recruiting
Phase
First received
Last updated
Start date January 2008
Est. completion date December 2025

Study information
Verified date April 2022
Source University Hospital, Lille
Contact Frédéric Gottrand, MD,PhD
Email frederic.gottrand@chru-lille.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 ...). 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 2500
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group N/A to 1 Year
Eligibility Inclusion Criteria: - To be born in France - To have a esophageal atresia Exclusion Criteria: - To be born abroad

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• data collection

Locations
Country Name City State
France CHU Amiens-Picardie Amiens
France CHU d'Angers Angers
France CHRU Besançon Besançon
France CHU de Bordeaux Bordeaux
France CHRU Brest Brest
France HFME de Lyon Bron
France CHU de Caen Caen
France CHU de Clermont-Ferrand Clermont-Ferrand
France Hôpitaux Civils de Colmar Colmar
France CHI Créteil Créteil
France CHU Dijon Bourgogne Dijon
France CHU de Grenoble La Tronche
France AP-HP CHU Kremlin-Bicêtre Le Kremlin-Bicêtre
France CH Le Mans Le Mans
France CHRU,Hôpital Jeanne de Flandres Lille
France CHU de Limoges Limoges
France AP-HM La Timone Marseille
France AP-HM Nord Marseille
France CHRU de Montpellier Montpellier
France CHU de Nantes Nantes
France CHU de Nice Nice
France CHR d'Orléans Orléans
France AP-HP Armand Trousseau Paris
France AP-HP Necker-Enfants malades Paris
France AP-HP Robert-Debré Paris
France CHU de Poitiers Poitiers
France CHU de Reims Reims
France CHU de Rennes Rennes
France CHU de Rouen Rouen
France CHU Félix-Guyon Saint Denis La Réunion
France CHU de Saint-Etienne Saint-Priest en Jarez
France CHU de Strasbourg Strasbourg
France CHU de Toulouse Toulouse
France CHRU de Tours Tours
France CHU de Nancy Vandœuvre-lès-Nancy
Guadeloupe CHU de Pointe-à-Pitre Pointe-à-Pitre
Martinique CHU de Martinique Fort-de-France

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Lille

Countries where clinical trial is conducted

France,  Guadeloupe,  Martinique, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of esophageal atresia 10 years
Secondary Data collection patient with esophageal atresia Circumstances of diagnosis, modalities of follow-up and clinical management 10 years
Secondary Total number of patients with complications 10 years
Secondary Death 10 years
See also
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Completed NCT03615495 - Flourish™ Pediatric Esophageal Atresia
Recruiting NCT05995171 - Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence
Completed NCT04901546 - Esophageal Atresia: a Natural Experiment of the Effects of Oral Inoculation on the Gut Microbiome N/A
Recruiting NCT03730454 - Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair N/A
Recruiting NCT03455881 - Phenotypic and Genetic Assessment of Tracheal and Esophageal Birth Defects in Patients
Completed NCT05527873 - Respiratory Complications of Operated Esophageal Atresia in Children
Completed NCT04932746 - The Effect of Dexmedetomidine on Oxygen During One Lung Ventilation in Pediatric Surgery. N/A
Not yet recruiting NCT04259528 - Endoscopic Ultrasound Findings in Esophageal Atresia Following Surgical Repair N/A
Recruiting NCT06073158 - Molecular Signatures of Esophageal Atresia N/A
Not yet recruiting NCT03999008 - Oral Viscous Budesonide in Anastomotic Stricture After Esophageal Atresia Repair (OVB in EA) N/A
Completed NCT03415893 - High-resolution Esophageal Manometry N/A
Not yet recruiting NCT03023865 - Individualized Management for Long Gap Esophageal Atresia N/A
Not yet recruiting NCT04136795 - Evaluation of the Respiratory Impact After Conventional or Minimally Invasive Esophageal Atresia Surgery
Recruiting NCT03619408 - Management of Esophagitis Following Repair of Esophageal Atresia
Completed NCT05129930 - Fluid Overload and Pulmonary Function
Completed NCT02033772 - Prospective Data Collection of Patients < 6 Months of Age Undergoing Thoracoscopic Surgery N/A
Recruiting NCT03767673 - Cardiorespiratory Performance and Pulmonary Microbiome in Patients After Repair of Esophageal Atresia N/A

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