Dumping Syndrome, Oesophageal Atresia
Conditions
Keywords
infants, oesophageal atresia, dumping syndrome, prevalence, Type III and IV, Oral glucose tolerance test, early hyperglycemia, late hypoglycemia
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.
Interventions
BIOLOGICALOral 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.
Sponsors
University Hospital, Lille
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 14 Weeks
Healthy volunteers
No
Inclusion criteria
* New born less than 3.5 months or age corrected for premature new born * Weight ≥ 4, 150 kg * Esophageal atresia (EA) type III or IV * EA Surgery between May 2013 and June 2016 * Stop of prokinetic treatment \> 72 h before OGTT * Information and consent of parents * Patients with health insurance
Exclusion criteria
* Age \> 3.5 months * Weight \< 4.150 kg * Other types of EA * Dumping syndrom from other origin: microgastria, dysautonomia, small intestine surgery * Other pathology that can modify glycemia: neonatal diabete, hyperinsulinism * Treatment that can modify gastric motility: domperidone, erythromycin, baclofen that hasn't been stopped in the 72h before OGTT * Absence of consent * Patient judiciary protected * Simultaneous participation to another clinical trial * No health insurance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early hyperglycemia during Oral Glucose Tolerance Test (OGTT) | up to 240 min | Hypoglycemia : glycemia \< 0,6 g/L |
| Late hypoglycemia during OGTT | up to 240 min | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical signs presenting consequently to OGTT | continuous monitoring during 240 minutes | 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 |
| Associated pathologies | 1 day | neurologic, extremities, ribbs and vertebrales, genito-urinary, renal, cardiovascular, ano-rectal, microgastria and others. Syndromic associations are also noted, as VACTERL and charge syndroms. |
| Surgery details | 1 day | 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 |
| Post-surgery complications | 1 day | anastomotic leakage, mediastinitis |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORLaurent Michaud, MD
University Hospital, Lille
Outcome results
None listed