Dumping Syndrome After Operation of Esophageal Atresia Type III (DUMPING)

University Hospital, Lille

Status

Completed

Conditions

Oesophageal Atresia

Dumping Syndrome

Treatments

Biological: Oral Glucose

Study type

Interventional

Funder types

Other

Identifiers

NCT02525705

2010-A00217-32 (Other Identifier)

2009_42/1004

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 patients

Sex

All

Ages

Under 14 weeks old

Volunteers

No Healthy Volunteers

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