An observational study in Esophageal Atresia, sponsored by University Hospital, Lille. Recruiting at 33 sites in 3 countries. Open to participants aged 13 Years to 14 Years. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by University Hospital, Lille · Observational
Oesophageal atresia (OAEA), a malformation of the oesophagus present from birth, is characterized by the interruption of the continuity of the oesophagus, which then ends in a cul-de-sac. (Source: Fimatho) An operation is then required to restore continuity to the esophagus. Although this operation enables the vast majority of children to survive the neonatal period, health problems such as gastro-oesophageal reflux, eating difficulties, respiratory problems and growth problems persist throughout life.
The aim of the project is to create a prospective cohort of adolescents aged 13/14, nested in the national AO registry. of adolescents born with esophageal atresia, including a biobank of esophageal mucosa and plasma blood samples. Once the clinical and omic data have been collected, the data will be transferred to the France Cohortes information system for analysis, in order to assess the long-term outcome of this rare disease and establish multi-omic profiles. Once the clinical data have been collected and the omics data (derived from analysis of the biobank's biological samples) have been generated, they will be analyzed by the project partners to assess the long-term outcome of OA and establish multiomic profiles. The raw data will be available on the France Cohorte platform.
37 studies on the registry are indexed under Esophageal Atresia; 12 are open to participants now.
This study's planned enrollment of 300 is above the median of 50 across 19 observational studies indexed under Esophageal Atresia.
Browse Esophageal Atresia studies →University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.
Counted across the registry records on this site, refreshed daily.
children aged 13 to 14 born with oesophageal atresia
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For the blood sub-study :
For the control arm:
Exclusion Criteria:
For the control arm :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient with esophageal atresia
Other: Questionnaire
Patient without esophageal atresia
Other: Questionnaire
Quality of life questionnaires will be used specifically for this research: Pediatric Quality of Life Invertory and EA-QoL
prevalence of gastroesophageal reflux disease (GERD) in children born with esophageal atresia
GERD = \[pH/impedance-metry demonstrating pathological GERD and/or if lesions of peptic esophagitis are observed at an endoscopy in the year preceding the visit or if the child has a history of complicated GERD leading to anti-reflux surgery\]
Time frame: 13-14 years
Quality of life, nutritional status and respiratory complications
Quality of life= EA-QoL and PedsQL The quality of life of patients in adolescence will be assessed by means of the following quality of life scales at the age of 13-14 years: PedsQL (13) and EA-QoL (11) by both the patient and a parent. Scale scores will be calculated in accordance with the authors' instructions. * Nutritional status will be assessed by weight and height, and by calculating the weight/height z-score and BMI z-score using the World Health Organisation growth curves as a reference (14). * Frequency of respiratory complications, assessed during clinical examination (hacking cough during infections, chronic cough, asthma, exertional symptoms (cough, dyspnoea), atopy, wheezing and/or stridor/corniness).
Time frame: 13-14 years
Omics and multi omics profiles in plasma
Time frame: 13-14 years
Factors associated with GERD
It will be determined from patient characteristics at birth, 1 year, 6 years and 13-14 years (ante-natal data, vital signs, presence of associated malformations, type of atresia, surgical procedures performed, surgical/digestive/respiratory/neuro-orthopaedic complications, type of diet and schooling).
Time frame: Birth,1 year, 6 years and 13-14 years
Omics and multi omics profiles in esophageal biopsiesfor patient having 1 biopsy
metabolites, proteins and methylation
Time frame: 13-14 years
Omics and multi omics profiles in esophageal biopsies for patient having more than 1 biopsy
metabolites, proteins and methylation
Time frame: 13-14 years
Plan to share: No
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