Dumping syndrome after oesophageal atresia repair
Physiopathology of Dumping Syndrome in Esophageal Atresia
NA · University Hospital, Lille · NCT04522193
This study will test continuous glucose and heart monitoring plus a gastric emptying scan in babies born with oesophageal atresia to see if these tests detect dumping syndrome and dangerous drops in blood sugar after feeds.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 2 Months to 3 Months |
| Sex | All |
| Sponsor | University Hospital, Lille (other) |
| Locations | 2 sites (Lille and 1 other locations) |
| Trial ID | NCT04522193 on ClinicalTrials.gov |
What this trial studies
Dumping syndrome is common after oesophageal atresia repair and can cause dangerous postprandial hypoglycaemia in infants. This protocol enrolls infants aged 2 to 3 months who were operated at birth for type C oesophageal atresia and who are off prokinetic medication. Participants will receive continuous glycemic monitoring (glycemic Holter), continuous cardiac monitoring (Holter ECG), and a gastric emptying scintigraphy at about three months of age. The study aims to correlate feeding-related symptoms with glucose, cardiac, and gastric emptying measures to better understand the mechanisms behind dumping syndrome.
Who should consider this trial
Good fit: Infants aged 2 to 3 months who were operated at birth for oesophageal atresia type C and who can stop prokinetic drugs at least 72 hours before monitoring are ideal candidates.
Not a fit: Babies with other causes of dumping syndrome, disorders that alter glycaemic regulation, or those on treatments that modify gastric motility are unlikely to benefit from this protocol's findings.
Why it matters
Potential benefit: If successful, the approach could allow earlier diagnosis and more targeted care to prevent post-meal hypoglycaemia and its complications in infants with oesophageal atresia.
How similar studies have performed: Continuous glucose monitoring and gastric emptying scans have been useful in older patients with dumping or gastric motility disorders, but using this combined approach in neonates with oesophageal atresia is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients operated at birth for Oesophageal atresia type C * Aged from 2 to 3 months at inclusion * Off prokinetic treatment (suspended for at least 72 hours) before monitoring Exclusion Criteria: * History of dumping syndrome of other cause (microgastria, fundoplication, dysautonomia..) * History of any disease that can modify glycemic regulation (hyperinsulinism, neonatal diabete) * Treatment that can modify gastric motility
Where this trial is running
Lille and 1 other locations
- Hôpital Jeanne de Flandres — Lille, France (NOT_YET_RECRUITING)
- Hôpital Jeanne de Flandre - Pôle enfant, CHU de Lille — Lille, France (RECRUITING)
Study contacts
- Principal investigator: Madelaine AUMAR, MD — University Hospital, Lille
- Study coordinator: Madelaine AUMAR, MD
- Email: madeleine.aumar@chru-lille.fr
- Phone: 0320445962
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Oesophageal Atresia, Dumping Syndrome, Oesophageal dysmotility, Oesophageal atresia, Post prandial hypoglycaemia, Gastric emptying troubles