Oral Viscous Budesonide in Anastomotic Stricture After Esophageal Atresia Repair (OVB in EA)

Not Applicable

• Conditions: Anastomotic Stenosis; Esophageal Atresia
• Interventions: Drug: Budesonide Oral; Drug: Placebos

• Registration Number: NCT03999008
• Lead Sponsor: St. Justine's Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-06-14
• Study First Submitted QC: 2019-06-24
• Last Update Submitted: 2019-06-24
• Study First Posted: 2019-06-26
• Last Update Posted: 2019-06-26
• Study Start: 2020-06-01
• Primary Completion: 2022-06-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Budesonide	Budesonide Oral	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
Placebo	Placebos	Placebo: 5 ml apple sauce BID plus 1 mL saline

Primary Outcome Measures

Name	Time	Method
number of dilations needed after randomization (beginning of treatment)	12 months	number of dilations needed after randomization (beginning of treatment)

Secondary Outcome Measures

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