Esophageal AtresiaOVB in EANCT03999008
Oral Viscous Budesonide in Anastomotic Stricture After Esophageal Atresia Repair (OVB in EA)
A study testing Budesonide Oral in people with Esophageal Atresia and Anastomotic Stenosis, run by St. Justine's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 3 years
- Conditions the study is for
- Esophageal Atresia, Anastomotic Stenosis
- What is being tested?
- Budesonide Oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 month to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
About this study
Official title: A Multicentre, Prospective, Randomized, Placebo Controlled, Double-blinded Study to Demonstrate Potential and Beneficial Effects of Oral Viscous Budesonide (OVB) in the Prevention of Recurrence of Anastomotic Stricture in Children Operated on for Esophageal Atresia With Recurrent Anastomotic Strictures
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.
- Conditions
- Esophageal Atresia, Anastomotic Stenosis
- Being tested
- Budesonide Oral, Placebos
- Medical subject headings
- Esophageal Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide OralDrug
The subjects will be included at time of the first dilation for an anastomotic stricture.
Basal physical exam and clinical evaluation (weight and height, dysphagia score, gastroesophageal reflux, feeding problems, respiratory symptoms, other symptoms).
Randomization will be conducted by centre. Because long gap esophageal atresia, high tension anastomosis and history of anastomotic leak are reported as risk factors for occurrence of anastomotic strictures, a stratification at randomization will be performed according to these criteria in each centre.
OVB or placebo will be given by the parents and started the day of the dilation at the first meal after recovering of the dilation and anesthesia.
Parents will be asked to bring the empty caps which will be counted for assessment of compliance.
PlacebosDrug
Apple Sauce 5 mL+ 1 mL saline
| Study group | Role | What they receive |
|---|---|---|
| Budesonide | Active comparator | Oral viscous budesonide will be given in apple sauce according to body weight at inclusion:
< 10 kg: 250 mcg BID in 5 ml apple sauce 10 kg to <15 kg: 500 mcg BID in 5 ml apple sauce >15 kg: 1000 mcg BID in 5 ml apple sauce Receives: Drug: Budesonide Oral |
| Placebo | Placebo comparator | Placebo: 5 ml apple sauce BID plus 1 mL saline Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of dilations needed after randomization (beginning of treatment)
number of dilations needed after randomization (beginning of treatment)
Measured: 12 months
Secondary outcomes (8)
Number of patients needing dilation after randomization (beginning of treatment)
Number of patients needing dilation after randomization (beginning of treatment)
Measured: 12 months
Number of patients needing more than 3 dilations after randomization
Number of patients needing more than 3 dilations after randomization
Measured: 12 months
Mean time to further dilation
Mean time to further dilation
Measured: 12 months
Number of patients treated with an adjuvant therapy
Number of patients treated with an adjuvant therapy
Measured: 12 months
Ability to tolerate normal food for age
Ability to tolerate normal food for age
Measured: 12 months
Dysphagia score
Dysphagia score
Measured: 12 months
Quantification of the anastomostic stricture by the Stricture index (SI) calculated on barium swallow at 12 months of age
Quantification of the anastomostic stricture by the Stricture index (SI) calculated on barium swallow at 12 months of age
Measured: 12 months
Side effects/Adverse events
Side effects/Adverse events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start1 Jun 2020 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christophe Faure, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999008
- Sponsor's protocol ID
- OVB in EA
- Acronym
- OVB in EA
- Status last verified
- Jun 2019
- First submitted
- 14 Jun 2019
- Last updated
- 26 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Prospective, Randomized, Placebo Controlled, Double-blinded Study to Demonstrate Potential and Beneficial Effects of Oral Viscous Budesonide (OVB) in the Prevention of Recurrence of Anastomotic Stricture in Children Operated on for Esophageal Atresia With Recurrent Anastomotic Strictures
- ClinicalTrials.gov ID
- NCT03999008
- Acronym / sponsor ID
- OVB in EA / OVB in EA
- Conditions
- Esophageal Atresia, Anastomotic Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 26 Jun 2019 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Budesonide | Active comparator | Drug: Budesonide OralOral viscous budesonide will be given in apple sauce according to body weight at inclusion: < 10 kg: 250 mcg BID in 5 ml apple sauce 10 kg to <15 kg: 500 mcg BID in 5 ml apple sauce >15 kg: 1000 mcg BID in 5 ml apple sauce |
| Placebo | Placebo comparator | Drug: PlacebosPlacebo: 5 ml apple sauce BID plus 1 mL saline |
Who may qualify
- Ages
- 1 month to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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 :
- Receiving an ongoing treatment by PPI 1 to 2 mg/kg die
- Informed parental consent
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Budesonide OralThe subjects will be included at time of the first dilation for an anastomotic stricture. Basal physical exam and clinical evaluation (weight and height, dysphagia score, gastroesophageal reflux, feeding problems, respiratory symptoms, other symptoms). Randomization will be conducted by centre. Because long gap esophageal atresia, high tension anastomosis and history of anastomotic leak are reported as risk factors for occurrence of anastomotic strictures, a stratification at randomization will be performed according to these criteria in each centre. OVB or placebo will be given by the parents and started the day of the dilation at the first meal after recovering of the dilation and anesthesia. Parents will be asked to bring the empty caps which will be counted for assessment of compliance. | Drug | Budesonide |
| PlacebosApple Sauce 5 mL+ 1 mL saline | Drug | Placebo |
Primary outcome
number of dilations needed after randomization (beginning of treatment)
Time frame: 12 months
number of dilations needed after randomization (beginning of treatment)
8 secondary outcomes
Number of patients needing dilation after randomization (beginning of treatment)
Time frame: 12 months
Number of patients needing more than 3 dilations after randomization
Time frame: 12 months
Mean time to further dilation
Time frame: 12 months
Number of patients treated with an adjuvant therapy
Time frame: 12 months
Ability to tolerate normal food for age
Time frame: 12 months
Dysphagia score
Time frame: 12 months
Quantification of the anastomostic stricture by the Stricture index (SI) calculated on barium swallow at 12 months of age
Time frame: 12 months
Side effects/Adverse events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Budesonide Oral in people with Esophageal Atresia and Anastomotic Stenosis, run by St. Justine's Hospital.
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 9 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of dilations needed after randomization (beginning of treatment) (time frame: 12 months). 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 26 Jun 2019.