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Recruiting NCT04522193

NCT04522193 Dumping Syndrome and Esophageal Atresia

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Clinical Trial Summary
NCT ID NCT04522193
Status Recruiting
Phase
Sponsor University Hospital, Lille
Condition Oesophageal Atresia
Study Type INTERVENTIONAL
Enrollment 15 participants
Start Date 2024-02-23
Primary Completion 2026-11

Eligibility & Interventions

Sex All sexes
Min Age 2 Months
Max Age 3 Months
Study Type INTERVENTIONAL
Interventions
Glycemic Holtergastric emptying scintigraphyHolter ECG

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 15 participants in total. It began in 2024-02-23 with a primary completion date of 2026-11.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

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

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

Contact & Investigator

Central Contact

Madelaine AUMAR, MD

✉ madeleine.aumar@chru-lille.fr

📞 0320445962

Principal Investigator

Madelaine AUMAR, MD

PRINCIPAL INVESTIGATOR

University Hospital, Lille

Frequently Asked Questions

Who can join the NCT04522193 clinical trial?

This trial is open to participants of all sexes, aged 2 Months or older, up to 3 Months, studying Oesophageal Atresia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT04522193 currently recruiting?

Yes, NCT04522193 is actively recruiting participants. Contact the research team at madeleine.aumar@chru-lille.fr for enrollment information.

Where is the NCT04522193 trial being conducted?

This trial is being conducted at Lille, France, Lille, France.

Who is sponsoring the NCT04522193 clinical trial?

NCT04522193 is sponsored by University Hospital, Lille. The principal investigator is Madelaine AUMAR, MD at University Hospital, Lille. The trial plans to enroll 15 participants.

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