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Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence

ConditionEsophageal Atresia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age13-14
SponsorUniversity Hospital, Lille

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Born with oesophageal atresia (EA) in France or in French overseas departments and territories

Anastomosis performed

Included into the ReNaTo registry

Aged 13 or 14 during the recruitment period

Disqualifiers

Concurrent participation in an interventional trial and in the 3 months prior to inclusion

Parents refusing to participate in the study

Histologically non-normal esophageal biopsy

Parents refusing to participate in the study

Trial population

children aged 13 to 14 born with oesophageal atresia

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Questionnaire

    Other intervention

    Quality of life questionnaires will be used specifically for this research: Pediatric Quality of Life Invertory and EA-QoL

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Esophageal atresia arm1 intervention
Group B: control arm1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

Omics and multi omics profiles in plasma

Time frame
13-14 years
3

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
4

Omics and multi omics profiles in esophageal biopsiesfor patient having 1 biopsy

metabolites, proteins and methylation

Time frame
13-14 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Lille

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Collaborator

Source ClinicalTrials.gov
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