EUCTR2018-002863-24-FR
Active, not recruiting
Phase 1
Intralesional steroids injections to prevent refractory strictures in patients with esophageal atresia - a randomized controlled tiral - STEPS-EA
Erasmus Universitu Medical Center - Sophia Children's Hospital0 sites110 target enrollmentFebruary 24, 2021
Conditionsrefractory strictures in patients with esophageal atresiaMedDRA version: 20.0Level: PTClassification code 10021530Term: Imperforate oesophagusSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
DrugsKenacort-A 10 mg-ml
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- refractory strictures in patients with esophageal atresia
- Sponsor
- Erasmus Universitu Medical Center - Sophia Children's Hospital
- Enrollment
- 110
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Children with EA type C who underwent primary anastomotic surgery within the first days of life
- •\- Age 3 months at the time of the 3rd dilatation
- •\- In need of a 3rd dilatation
- •\- Written informed consent by both parents or legal representatives, if applicable
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range 0
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range 0
Exclusion Criteria
- •\- Age \<3 months
- •\- Known inability from previous dilatations to use an endoscope with a size of 5\.8 mm
- •\- No parental written informed consent
Outcomes
Primary Outcomes
Not specified
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