Oral Viscous Budesonide in Anastomotic Stricture After Esophageal Atresia Repair (OVB in EA) (NCT03999008) | Clinical Trial Compass
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Oral Viscous Budesonide in Anastomotic Stricture After Esophageal Atresia Repair (OVB in EA)
60 participantsStarted 2020-06-01
Plain-language summary
The aim of this study is to perform a multicentre, prospective, randomized, placebo controlled, double-blinded study to demonstrate the potential and beneficial effects of OVB in the prevention of recurrence of anastomotic stricture in children operated for esophageal atresia with an anastomotic stricture.
Who can participate
Age range
1 Month – 3 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Children aged \> 1 month to 3 years
* Operated for an esophageal atresia of all types except pure TEF.
* Presence of an anastomotic stricture defined according to experts recommendations :
* a relative esophageal narrowing at the level of the anastomosis,
* demonstrated by a contrast study and/or an endoscopy
* with significant functional impairment and associated symptoms requiring dilation.
* Symptoms include: feeding or swallowing difficulties, coughing and choking during feeds, food impaction, regurgitation/vomiting of undigested food, drooling. In very young patients: apnea and food refusal.
* Receiving an ongoing treatment by PPI 1 to 2 mg/kg die
* Informed parental consent
Exclusion Criteria:
* Known immune deficiency
* Acute respiratory or intestinal infection
* Severe respiratory, cardiac or neurological condition precluding OVB or placebo swallowing
* Child fed exclusively via nasogastric tube or gastrostomy
* Absence of parental consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is testing oral viscous budesonide to reduce the number of dilations needed after esophageal atresia repair, can you explain how many dilations my child is currently expected to need, and whether adding this medication could realistically change that number?
2The trial's recruitment status is listed as unknown — do you know if this study is still actively enrolling patients, and if not, are there other similar studies or clinical settings where oral viscous budesonide is being used for anastomotic stricture?
3Because this trial doesn't have a traditional numbered phase, what does that tell us about how much is already known about the safety of oral viscous budesonide in children with esophageal atresia, and are there any steroid-related risks I should be aware of?
4How does participating in this trial compare to continuing with dilation alone as standard care — would joining the study mean my child might receive a placebo instead of the budesonide, or would everyone get the medication?
5What would participation in this trial actually look like day-to-day for our family — how often would my child need clinic visits, medication doses, or follow-up procedures compared to what we'd already be doing outside the trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
number of dilations needed after randomization (beginning of treatment)