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Dumping Syndrome and Esophageal Atresia

ConditionsOesophageal AtresiaDumping Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-3
SponsorUniversity Hospital, Lille

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

  • Glycemic Holter

    Device

    Continuous glycaemia monitoring,

  • gastric emptying scintigraphy

    Radiation

    Fasting administration of a Technecium-labelled milk bottle and quantification of the remaining radioactivity by a camera every 30 minutes for 4 hours.

  • Holter ECG

    Device

    continuous cardiac monitoring

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Experimental groupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Abnormal glycaemia associated with vagal hypertonia

Composite criteria: association between abnormal glycaemia (high or low) and variations of cardiac frequency

Time frame
At least once during the 48 hours monitoring

Secondary outcomes

1

Abnormal glycaemia associated with abnormal gastric emptying

Composite criteria: association between abnormal glycaemia (high or low) and abnormal gastric emptying study

Time frame
At least once during the 48 hours monitoring
2

Persistance of dumping syndrome

measured by a gastric emptying scintigraphy

Time frame
At the age of 6 months
3

Tolerance of glucose monitoring

Occurrence of side effects or technical issues during monitoring

Time frame
At least once during the 48 hours monitoring

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Lille

Lead sponsor

Groupement Interrégional de Recherche Clinique et d'Innovation

Collaborator

french patient association for oesophageal atresia AFAO

Collaborator

Source ClinicalTrials.gov
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