Oesophageal AtresiaDUMTORINGNCT04522193
Dumping Syndrome and Esophageal Atresia
A study testing Glycemic Holter, gastric emptying scintigraphy and Holter ECG in people with Oesophageal Atresia and Dumping Syndrome, run by University Hospital, Lille at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 3 months
- Conditions the study is for
- Oesophageal Atresia, Dumping Syndrome
- What is being tested?
- Glycemic Holter, gastric emptying scintigraphy and Holter ECG
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesFrance
- Study dates
- 23 Feb 2024to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
Hôpital Jeanne de Flandres
Lille, 59037
0320445962
Madelaine AUMAR, MD
- Recruiting
Hôpital Jeanne de Flandre - Pôle enfant, CHU de Lille
Lille
Madeleine AUMAR
About this study
Official title: Physiopathology of Dumping Syndrome in Esophageal Atresia
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
- Conditions
- Oesophageal Atresia, Dumping Syndrome
- Being tested
- Glycemic Holter, gastric emptying scintigraphy, Holter ECG
- Keywords
- Oesophageal dysmotility, Oesophageal atresia, Post prandial hypoglycaemia, Gastric emptying troubles
- Medical subject headings
- Esophageal Atresia, Dumping Syndrome, Esophageal Motility Disorders, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycemic HolterDevice
Continuous glycaemia monitoring,
gastric emptying scintigraphyRadiation
Fasting administration of a Technecium-labelled milk bottle and quantification of the remaining radioactivity by a camera every 30 minutes for 4 hours.
Holter ECGDevice
continuous cardiac monitoring
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | All children born at the Lille University Hospital during the investigation period with esophageal atresia type III or IV Receives: Device: Glycemic Holter; Radiation: gastric emptying scintigraphy; Device: Holter ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abnormal glycaemia associated with vagal hypertonia
Composite criteria: association between abnormal glycaemia (high or low) and variations of cardiac frequency
Measured: At least once during the 48 hours monitoring
Secondary outcomes (3)
Abnormal glycaemia associated with abnormal gastric emptying
Composite criteria: association between abnormal glycaemia (high or low) and abnormal gastric emptying study
Measured: At least once during the 48 hours monitoring
Persistance of dumping syndrome
measured by a gastric emptying scintigraphy
Measured: At the age of 6 months
Tolerance of glucose monitoring
Occurrence of side effects or technical issues during monitoring
Measured: At least once during the 48 hours monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start23 Feb 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oesophageal AtresiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Groupement Interrégional de Recherche Clinique et d'Innovation, french patient association for oesophageal atresia AFAO
- Responsible party
- Sponsor
- Investigators
- Madelaine AUMAR, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522193
- Sponsor's protocol ID
- 2019_51
- Other IDs
- 2020-A01938-31
- Acronym
- DUMTORING
- Status last verified
- Dec 2025
- First submitted
- 18 Aug 2020
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiopathology of Dumping Syndrome in Esophageal Atresia
- ClinicalTrials.gov ID
- NCT04522193
- Acronym / sponsor ID
- DUMTORING / 2019_51
- Conditions
- Oesophageal Atresia, Dumping Syndrome
- Keywords
- Oesophageal dysmotility, Oesophageal atresia, Post prandial hypoglycaemia, Gastric emptying troubles
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Groupement Interrégional de Recherche Clinique et d'Innovation, french patient association for oesophageal atresia AFAO
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 21 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Glycemic Holter, Radiation: gastric emptying scintigraphy, Device: Holter ECGAll children born at the Lille University Hospital during the investigation period with esophageal atresia type III or IV |
Who may qualify
- Ages
- 2 to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glycemic HolterContinuous glycaemia monitoring, | Device | Experimental group |
| gastric emptying scintigraphyFasting administration of a Technecium-labelled milk bottle and quantification of the remaining radioactivity by a camera every 30 minutes for 4 hours. | Radiation | Experimental group |
| Holter ECGcontinuous cardiac monitoring | Device | Experimental group |
Primary outcome
Abnormal glycaemia associated with vagal hypertonia
Time frame: At least once during the 48 hours monitoring
Composite criteria: association between abnormal glycaemia (high or low) and variations of cardiac frequency
3 secondary outcomes
Abnormal glycaemia associated with abnormal gastric emptying
Time frame: At least once during the 48 hours monitoring
Persistance of dumping syndrome
Time frame: At the age of 6 months
Tolerance of glucose monitoring
Time frame: At least once during the 48 hours monitoring
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Madelaine AUMAR, MD principal investigator
University Hospital, Lille
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glycemic Holter, gastric emptying scintigraphy and Holter ECG in people with Oesophageal Atresia and Dumping Syndrome, run by University Hospital, Lille at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madelaine AUMAR, MD (0320445962, madeleine.aumar@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abnormal glycaemia associated with vagal hypertonia (time frame: At least once during the 48 hours monitoring). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.