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

NCT03999008 | Unknown

• 1 other identifier: OVB in EA
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Esophageal Atresia; Anastomotic Stenosis

Outcome Measures

Primary Outcomes (1)

• number of dilations needed after randomization (beginning of treatment)

  number of dilations needed after randomization (beginning of treatment)

  12 months

Secondary Outcomes (8)

• Number of patients needing dilation after randomization (beginning of treatment)

  12 months

• Number of patients needing more than 3 dilations after randomization

  12 months

• Mean time to further dilation

  12 months

• Number of patients treated with an adjuvant therapy

  12 months

• Ability to tolerate normal food for age

  12 months

Study Arms (2)

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

Drug: Budesonide Oral

Placebo

PLACEBO COMPARATOR

Placebo: 5 ml apple sauce BID plus 1 mL saline

Drug: Placebos

Interventions

Budesonide Oral DRUG

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.

Budesonide

Placebos DRUG

Apple Sauce 5 mL+ 1 mL saline

Placebo

Eligibility Criteria

• Age: 1 Month - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Justine's Hospital: lead

MeSH Terms

Conditions

Esophageal Atresia

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: June 26, 2019
• Study Start: June 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2023
• Last Updated: June 26, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share