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

St. Justine's Hospital

Status: Unknown

Conditions: Esophageal Atresia; Anastomotic Stenosis

Treatments: Drug: Budesonide Oral; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT03999008

OVB in EA

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 1 month to 3 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Budesonide

Active Comparator group

Description:

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

Treatment:

Drug: Budesonide Oral

Placebo

Placebo Comparator group

Description:

Placebo: 5 ml apple sauce BID plus 1 mL saline

Treatment:

Drug: Placebos