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

St. Justine's Hospital0 sites60 target enrollmentJune 1, 2020

ConditionsEsophageal Atresia Anastomotic Stenosis

InterventionsBudesonide Oral Placebos

DrugsBudesonide Oral Placebos

Overview

Phase: Not Applicable
Intervention: Budesonide Oral
Conditions: Esophageal Atresia
Sponsor: St. Justine's Hospital
Enrollment: 60
Primary Endpoint: number of dilations needed after randomization (beginning of treatment)
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 1, 2020

End Date

June 1, 2023

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

St. Justine's Hospital

Responsible Party

Principal Investigator

Christophe Faure

Principal Investigator

St. Justine's Hospital

Eligibility Criteria

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

Arms & Interventions

Budesonide

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

Intervention: Budesonide Oral

Placebo

Placebo: 5 ml apple sauce BID plus 1 mL saline

Intervention: Placebos

Outcomes

Primary Outcomes

number of dilations needed after randomization (beginning of treatment)

Time Frame: 12 months

number of dilations needed after randomization (beginning of treatment)

Secondary Outcomes

Mean time to further dilation(12 months)
Number of patients needing more than 3 dilations after randomization(12 months)
Ability to tolerate normal food for age(12 months)
Quantification of the anastomostic stricture by the Stricture index (SI) calculated on barium swallow at 12 months of age(12 months)
Number of patients needing dilation after randomization (beginning of treatment)(12 months)
Dysphagia score(12 months)
Number of patients treated with an adjuvant therapy(12 months)
Side effects/Adverse events(12 months)