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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A01938-31 | Other Identifier | ID-RCB number,ANSM |
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| Name | Class |
|---|---|
| Groupement Interrégional de Recherche Clinique et d'Innovation | OTHER |
| french patient association for oesophageal atresia AFAO | UNKNOWN |
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Dumping syndrome (DS) is frequent in oesophageal atresia (29%). In causing hypoglycaemia, it can be dangerous for neonates. Mechanisms of DS are actually partialy understood. This is also an affection difficult to diagnose, because it only occurs after meals and can be inconstantly present. To date, their is only symptomatic treatment for DS. This study aims to understand its pathological mechanisms so as to better treat it and avoid its consequences. Oesophageal atresia patients enrolled in this study will benefit from a continuous glycemic monitoring, a continuous cardiac monitoring, and an a gastric emptying scintigraphy at the age of 3 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | All children born at the Lille University Hospital during the investigation period with esophageal atresia type III or IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glycemic Holter | Device | Continuous glycaemia monitoring, |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Abnormal glycaemia associated with vagal hypertonia | Composite criteria: association between abnormal glycaemia (high or low) and variations of cardiac frequency | At least once during the 48 hours monitoring |
| Measure | Description | Time Frame |
|---|---|---|
| Abnormal glycaemia associated with abnormal gastric emptying | Composite criteria: association between abnormal glycaemia (high or low) and abnormal gastric emptying study | At least once during the 48 hours monitoring |
| Persistance of dumping syndrome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Madelaine AUMAR, MD | Contact | 0320445962 | madeleine.aumar@chru-lille.fr |
| Name | Affiliation | Role |
|---|---|---|
| Madelaine AUMAR, MD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Jeanne de Flandres | Not yet recruiting | Lille | 59037 | France |
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| ID | Term |
|---|---|
| D004933 | Esophageal Atresia |
| D004377 | Dumping Syndrome |
| D015154 | Esophageal Motility Disorders |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D004065 | Digestive System Abnormalities |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D015716 | Electrocardiography, Ambulatory |
| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
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| gastric emptying scintigraphy |
| Radiation |
Fasting administration of a Technecium-labelled milk bottle and quantification of the remaining radioactivity by a camera every 30 minutes for 4 hours. |
|
| Holter ECG | Device | continuous cardiac monitoring |
|
measured by a gastric emptying scintigraphy
| At the age of 6 months |
| Tolerance of glucose monitoring | Occurrence of side effects or technical issues during monitoring | At least once during the 48 hours monitoring |
| Hôpital Jeanne de Flandre - Pôle enfant, CHU de Lille | Recruiting | Lille | France |
|
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011178 | Postgastrectomy Syndromes |
| D013272 | Stomach Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003680 | Deglutition Disorders |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
| D018670 | Monitoring, Ambulatory |
| D008991 | Monitoring, Physiologic |