Ongoing Clinical Trials for Oesophageal Atresia
There is currently 1 ongoing clinical trial investigating treatments for oesophageal atresia, a birth defect affecting the esophagus. This trial focuses on preventing complications after surgical repair in children, specifically testing steroid injections to reduce the formation of strictures (narrowings) that can make swallowing difficult.
Clinical trial locations
- Denmark
- Finland
- France
- Netherlands
- Sweden
Study on Triamcinolone Acetonide Injections to Prevent Esophageal Strictures in Children with Esophageal Atresia
This clinical trial, known as the STEPS-EA trial, is studying whether steroid injections can help prevent a common complication in children who have had surgery to repair oesophageal atresia. When babies are born with this condition, their esophagus (the tube connecting the mouth to the stomach) is incomplete. After surgical repair, scar tissue can form, creating narrowings called strictures that make swallowing difficult. These strictures often require repeated procedures called dilatations to widen the esophagus again.
Main inclusion criteria: The trial is looking for children who meet specific requirements. Participants must have had type C oesophageal atresia and undergone surgery to connect the esophagus within the first days of life. Children must be at least 3 months old and need to be scheduled for their third or fourth dilatation procedure. Both parents or legal representatives must provide written informed consent for the child to participate.
Main exclusion criteria: Children cannot participate if they have not had surgical repair for the condition, if they do not have strictures after repair, if they fall outside the specified age range, or if they belong to a vulnerable population requiring special protection.
Focus and goal: The primary goal is to determine whether intralesional steroid injections can prevent strictures from becoming severe and difficult to treat. Researchers want to see if this treatment can reduce the number of dilatation procedures needed over a 28-day period. The study will track participants for up to 6 months, recording how many dilatation procedures each child requires during this time. This information will help doctors understand whether this approach can improve quality of life by reducing the need for repeated procedures.
Investigational drug: The medication being tested is triamcinolone acetonide, a corticosteroid that is injected directly into the affected area of the esophagus. This type of steroid works by reducing inflammation and suppressing the immune response, which helps prevent the formation of scar tissue that leads to strictures. The medication is delivered through local injections at the site where it is needed. Some children will receive the steroid injection, while others will receive a placebo, allowing researchers to compare the results and determine the treatment’s effectiveness.
Summary
Currently, there is one active clinical trial investigating treatments for oesophageal atresia and its complications. This international study is being conducted across five European countries: Denmark, Finland, France, the Netherlands, and Sweden. The trial specifically focuses on children who have undergone surgical repair and are experiencing strictures, using triamcinolone acetonide injections as a potential preventive treatment. The concentration of this trial across multiple Nordic and Western European countries suggests a collaborative effort to gather sufficient data about this rare birth defect. The focus on corticosteroid injections represents an approach to reduce the burden of repeated procedures on young patients and their families.
