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Search / Trial NCT03999008

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

Launched by ST. JUSTINE'S HOSPITAL · Jun 24, 2019

Trial Information

Current as of August 11, 2025

Unknown status

Keywords

ClinConnect Summary

No description provided

Gender

ALL

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

About St. Justine's Hospital

St. Justine's Hospital is a leading pediatric healthcare institution dedicated to advancing child health through innovative clinical research. Renowned for its commitment to excellence in patient care and medical education, the hospital serves as a vital center for clinical trials aimed at improving therapeutic options for children. With a multidisciplinary team of experts, St. Justine's Hospital leverages cutting-edge technology and evidence-based practices to facilitate groundbreaking studies that address a wide range of pediatric conditions, ensuring the highest standards of safety and efficacy for its young patients.

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Timeline

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Trial launched

Trial updated

Estimated completion

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