Trials / Completed
CompletedNCT02525705
Dumping Syndrome After Operation of Esophageal Atresia Type III
Frequency of Occurrence of Dumping Syndrome After Operation of Esophageal Atresia Type III
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- University Hospital, Lille · Academic / Other
- Sex
- All
- Age
- 14 Weeks
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2011-06-14
- Primary completion
- 2018-01-15
- Completion
- 2018-01-15
- First posted
- 2015-08-17
- Last updated
- 2019-08-05
Locations
10 sites across 1 country: France
Source: ClinicalTrials.gov record NCT02525705. Inclusion in this directory is not an endorsement.