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Clinical Trials/NCT02883725
NCT02883725CompletedNot Applicable

National Register of Oesophageal Atresia

University Hospital, Lille74 sites in 3 countries1,460 target enrollmentStarted: January 1, 2008Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
1,460
Locations
74
Primary Endpoint
Number of esophageal atresia

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
— to 1 Year (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • To be born abroad

Arms & Interventions

Esophageal atresia

Intervention: data collection (Other)

Outcomes

Primary Outcomes

Number of esophageal atresia

Time Frame: 10 years

Secondary Outcomes

  • Death(10 years)
  • Data collection patient with esophageal atresia(10 years)
  • Total number of patients with complications(10 years)

Investigators

Sponsor
University Hospital, Lille
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (74)

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