NCT05527873

Brief Summary

The respiratory complications of esophageal atresia have already been identified. They are mainly related to tracheomalacia linked to the esophageal malformation, and are aggravated by frequently associated gastroesophageal reflux. In this context, symptoms of asthma (or bronchial hyperreactivity) occur more frequently than in the general population and persist into adulthood. Their pathogenesis is still poorly understood and is the subject of much discussion. The therapeutic management of these respiratory complications, poorly codified, remains very heterogeneous from one center to another. In France, the summary of knowledge is updated by the Reference Center for chronic and malformative diseases of the esophagus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

March 16, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 6, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2022

Completed
Last Updated

November 8, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

September 1, 2022

Last Update Submit

November 7, 2023

Conditions

Keywords

esophageal atresiaesophageal malformationgastroesophageal refluxasthmabronchial hyperreactivity

Outcome Measures

Primary Outcomes (1)

  • Retrospective study of respiratory complications of esophageal atresia in children

    Files analysed retrospectively from January 01, 2010 to December 31, 2020 will be examined

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Child aged 1 to 12 years old operated on for esophageal atresia and followed up at the University Hospitals of Strasbourg

You may qualify if:

  • Child aged 1 to 12 years old
  • Child operated on for esophageal atresia between 01/01/2010 and 31/12/2020 and followed up at the University Hospitals of Strasbourg
  • Child who has not expressed, after being informed, his opposition to the reuse of his data for the purposes of this research
  • Parental authority having not expressed, after being informed, their opposition to the reuse of their child's data for the purposes of this research.

You may not qualify if:

  • Subject and/or parental authority having expressed their opposition to participating in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Ressources et de Compétences de la Mucoviscidose (CRCM) - CHU de Strasbourg - France

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Esophageal AtresiaGastroesophageal RefluxAsthmaBronchial Hyperreactivity

Condition Hierarchy (Ancestors)

Digestive System AbnormalitiesDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEsophageal Motility DisordersDeglutition DisordersBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Laurence WEISS, MD

    Centre de Ressources et de Compétences de la Mucoviscidose (CRCM) - CHU de Strasbourg - France

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 1, 2022

First Posted

September 6, 2022

Study Start

March 16, 2022

Primary Completion

October 16, 2022

Study Completion

December 16, 2022

Last Updated

November 8, 2023

Record last verified: 2023-11

Locations