An interventional study of Oral Glucose in Oesophageal Atresia and Dumping Syndrome, sponsored by University Hospital, Lille. Completed at 10 sites in France. Open to participants aged Up to 14 Weeks. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by University Hospital, Lille · Not applicable, Interventional, and Prevention
The purpose of this study is to evaluate the prevalence at 3.5 months of age of dumping syndrome in children operated at birth for oesophageal atresia type III et IV.
Consecutive patients with type III and IV oesophageal atresia that are born in 8 different centers in France and Sydney (Australia) are included in the study, if willing. As soon as they weigh more than 4.150kg and if they are still younger than 3.5 months, an Oral Glucose Tolerance Test (OGTT) is performed. Glycemia and insulinemia are monitored every 30 minutes from intake to 240 minutes. Clinical signs that are presented are noted. If early hyperglycemia or late hypoglycemia are biologically or clinically observed, ascarbose treatment is initiated.
37 studies on the registry are indexed under Esophageal Atresia; 12 are open to participants now.
This study's enrollment of 42 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:
This is a one group interventional study. Every patient is included in the same arm.
Biological: Oral Glucose
1.75g/kg of glucose is orally taken by the patient. Capillary glycemia is systematically realised before ingestion (H0) and after 30, 60, 90, 120, 180 and 240 min and/or if clinical signs of hypoglycemia are presented by the patient.
Early hyperglycemia during Oral Glucose Tolerance Test (OGTT)
Hypoglycemia : glycemia \< 0,6 g/L
Time frame: up to 240 min
Late hypoglycemia during OGTT
Hyperglycemia : \> 1,8g/L from H0 to 30 min after oral intake, \> 1.7 between 1 and 2 h ours, \> 1.4 between 2 and 3 h , \> 1, 26 after 3 h
Time frame: up to 240 min
Clinical signs presenting consequently to OGTT
frequent clinical reflux (\>3/day), suspicion of esophagitis (pain while eating), colics, post-prandial diarrhea (liquid stools in the first hour after meal), abdominal pain, flatulence, pallor, hypotonia, agitation, convulsions, somnolence, sweat
Time frame: continuous monitoring during 240 minutes
Associated pathologies
neurologic, extremities, ribbs and vertebrales, genito-urinary, renal, cardiovascular, ano-rectal, microgastria and others. Syndromic associations are also noted, as VACTERL and charge syndroms.
Time frame: 1 day
Surgery details
postponed anastomosis, difficulty or tension in the suture, colic or gastric plasty if needed, tracheoscopy realisation, visualisation or damage of the X nerve, observation of a microgastria during surgery, other relevant informations of surgery
Time frame: 1 day
Post-surgery complications
anastomotic leakage, mediastinitis
Time frame: 1 day
Plan to share: No
Ran from Jun 2011 to primary completion in Jan 2018, 79 months.
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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Glucose