An interventional study of Glycemic Holter and gastric emptying scintigraphy in Oesophageal Atresia and Dumping Syndrome, sponsored by University Hospital, Lille. Recruiting at 2 sites in France. Open to participants aged 2 Months to 3 Months. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by University Hospital, Lille · Not applicable, Interventional, and Other
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
37 studies on the registry are indexed under Esophageal Atresia; 12 are open to participants now.
This study's planned enrollment of 15 is below the median of 50 across 17 interventional 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.
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Exclusion Criteria:
All children born at the Lille University Hospital during the investigation period with esophageal atresia type III or IV
Device: Glycemic Holter · Radiation: gastric emptying scintigraphy · Device: Holter ECG
Continuous glycaemia monitoring,
Fasting administration of a Technecium-labelled milk bottle and quantification of the remaining radioactivity by a camera every 30 minutes for 4 hours.
continuous cardiac monitoring
Abnormal glycaemia associated with vagal hypertonia
Composite criteria: association between abnormal glycaemia (high or low) and variations of cardiac frequency
Time frame: At least once during the 48 hours monitoring
Abnormal glycaemia associated with abnormal gastric emptying
Composite criteria: association between abnormal glycaemia (high or low) and abnormal gastric emptying study
Time frame: At least once during the 48 hours monitoring
Persistance of dumping syndrome
measured by a gastric emptying scintigraphy
Time frame: At the age of 6 months
Tolerance of glucose monitoring
Occurrence of side effects or technical issues during monitoring
Time frame: At least once during the 48 hours monitoring
Started Feb 2024 (actual). Primary completion is estimated for Nov 2026, 33 months after the start.
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