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Dumping Syndrome and Esophageal Atresia (DUMTORING)

U

University Hospital, Lille

Status

Enrolling

Conditions

Oesophageal Atresia
Dumping Syndrome

Treatments

Device: Glycemic Holter
Device: Holter ECG
Radiation: gastric emptying scintigraphy

Study type

Interventional

Funder types

Other

Identifiers

NCT04522193
2020-A01938-31 (Other Identifier)
2019_51

Details and patient eligibility

About

Dumping syndrome (DS) is frequent in oesophageal atresia (29%). In causing hypoglycaemia, it can be dangerous for neonates. Mechanisms of DS are actually partialy understood. This is also an affection difficult to diagnose, because it only occurs after meals and can be inconstantly present. To date, their is only symptomatic treatment for DS. This study aims to understand its pathological mechanisms so as to better treat it and avoid its consequences. Oesophageal atresia patients enrolled in this study will benefit from a continuous glycemic monitoring, a continuous cardiac monitoring, and an a gastric emptying scintigraphy at the age of 3 months

Enrollment

15 estimated patients

Sex

All

Ages

2 to 3 months old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

Experimental group
Experimental group
Description:
All children born at the Lille University Hospital during the investigation period with esophageal atresia type III or IV
Treatment:
Radiation: gastric emptying scintigraphy
Device: Holter ECG
Device: Glycemic Holter

Trial contacts and locations

2

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Central trial contact

Madelaine AUMAR, MD

Data sourced from clinicaltrials.gov

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