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OpenTrials
Completed

NCT Number: NCT02883725

National Register of Oesophageal Atresia

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.

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Key information

Conditions

Esophageal Atresia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases

Age range

Up to 1 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Félix-Guyon, Saint-Denis, La Réunion, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • To be born abroad

Treatment and study plan

Data Collection

Other

Primary outcomes

  1. Number of esophageal atresia

    Time frame: 10 years

Secondary outcomes

  1. Data collection patient with esophageal atresia

    Time frame: 10 years

    Circumstances of diagnosis, modalities of follow-up and clinical management

  2. Total number of patients with complications

    Time frame: 10 years

  3. Death

    Time frame: 10 years

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: REGATE

Important dates

Study start
2008
Primary completion
2016
Study completion
2019
First posted
Aug 30, 2016
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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