Esophageal Atresia Clinical Trial
— TransEAsomeOfficial title:
Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence
Verified date | February 2024 |
Source | University Hospital, Lille |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | November 14, 2026 |
Est. primary completion date | November 14, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 14 Years |
Eligibility | Inclusion Criteria: - For the oesophagal atresia group : - Born with oesophageal atresia (AO) in France or in French overseas departments and territories - Operated at birth for an AO - Aged 13 or 14 during the recruitment period - Patient willing to comply with all study procedures and duration For the blood sub-study : - Upper GI endoscopy performed as part of care between 13 and 14 years of age with esophageal mucosal biopsy sampling - Patient having given written consent to participate in the study For the control arm: - Aged 13 or 14 during the recruitment period - Upper GI endoscopy performed as part of care for chronic or acute digestive signs to rule out organic etiology (peptic esophagitis, gastric esophagitis, eosinophilic esophagitis or ulcer) - Normal endoscopy and histology - No chronic progressive disease Exclusion Criteria: - For the oesophagal atresia arm : - Concurrent participation in an interventional trial and in the 3 months prior to inclusion - Parents refusing to participate in the study For the control arm : - Histologically non-normal esophageal biopsy - Parents refusing to participate in the study - Child with known organic pathology |
Country | Name | City | State |
---|---|---|---|
France | CHU de Lille Hôpital Jeanne de Flandre | Lille | Nord |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille | Institut National de la Santé Et de la Recherche Médicale, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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] | 13-14 years | |
Secondary | the prevalence of GERD at 13-14 years of age | 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). | Birth,1 year, 6 years and 13-14 years | |
Secondary | 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). |
13-14 years | |
Secondary | Omics and multi omics profiles in esophageal biopsiesfor patient having 1 biopsie | metabolites, proteins and methylation | 13-14 years | |
Secondary | Omics and multi omics profiles in esophageal biopsies for patient having more than 1 biopsie | metabolites, proteins and methylation | 13-14 years | |
Secondary | Omics and multi omics profiles in plasma | 13-14 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04072419 -
Application of Enhanced Recovery After Surgery for Congenital Esophageal Atresia During Perioperative Period
|
||
Withdrawn |
NCT03127345 -
Omega 3 Fatty Acid Treatment for Pediatric Musculoskeletal Health
|
Phase 2 | |
Completed |
NCT00226044 -
Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.
|
Phase 3 | |
Completed |
NCT03615495 -
Flourishâ„¢ Pediatric Esophageal Atresia
|
||
Completed |
NCT04901546 -
Esophageal Atresia: a Natural Experiment of the Effects of Oral Inoculation on the Gut Microbiome
|
N/A | |
Recruiting |
NCT03730454 -
Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair
|
N/A | |
Recruiting |
NCT03455881 -
Phenotypic and Genetic Assessment of Tracheal and Esophageal Birth Defects in Patients
|
||
Completed |
NCT05527873 -
Respiratory Complications of Operated Esophageal Atresia in Children
|
||
Completed |
NCT04932746 -
The Effect of Dexmedetomidine on Oxygen During One Lung Ventilation in Pediatric Surgery.
|
N/A | |
Not yet recruiting |
NCT04259528 -
Endoscopic Ultrasound Findings in Esophageal Atresia Following Surgical Repair
|
N/A | |
Recruiting |
NCT06073158 -
Molecular Signatures of Esophageal Atresia
|
N/A | |
Not yet recruiting |
NCT03999008 -
Oral Viscous Budesonide in Anastomotic Stricture After Esophageal Atresia Repair (OVB in EA)
|
N/A | |
Completed |
NCT03415893 -
High-resolution Esophageal Manometry
|
N/A | |
Not yet recruiting |
NCT03023865 -
Individualized Management for Long Gap Esophageal Atresia
|
N/A | |
Recruiting |
NCT02883725 -
National Register of Oesophageal Atresia
|
||
Not yet recruiting |
NCT04136795 -
Evaluation of the Respiratory Impact After Conventional or Minimally Invasive Esophageal Atresia Surgery
|
||
Recruiting |
NCT03619408 -
Management of Esophagitis Following Repair of Esophageal Atresia
|
||
Completed |
NCT05129930 -
Fluid Overload and Pulmonary Function
|
||
Completed |
NCT02033772 -
Prospective Data Collection of Patients < 6 Months of Age Undergoing Thoracoscopic Surgery
|
N/A | |
Recruiting |
NCT03767673 -
Cardiorespiratory Performance and Pulmonary Microbiome in Patients After Repair of Esophageal Atresia
|
N/A |