Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-03-03 @ 5:44 AM
Study NCT ID:
NCT02525705
Status:
COMPLETED
Last Update Posted:
2019-08-05
First Post:
2015-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dumping Syndrome After Operation of Esophageal Atresia Type III
Sponsor:
University Hospital, Lille
Organization:
Study Overview
Official Title:
Frequency of Occurrence of Dumping Syndrome After Operation of Esophageal Atresia Type III
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DUMPING
Brief Summary:
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.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2010-A00217-32 | OTHER | ID-RCB number, ANSM | View |