Evaluating antacid therapy for esophagitis in children with repaired esophageal atresia
Management of Esophagitis Following Repair of Esophageal Atresia
This study is testing whether giving antacid medicine can help children with esophagitis who have had surgery for esophageal atresia feel better and how long they should take it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 30 Days to 17 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT03619408 on ClinicalTrials.gov |
What this trial studies
This study aims to prospectively assess the effects of antacid therapy on esophagitis in children who have undergone surgical repair for esophageal atresia. It seeks to identify risk factors associated with esophagitis and determine the optimal duration of antacid treatment. The study is based on recent clinical guidelines that highlight the need for a systematic approach to managing esophagitis in these patients, as existing evidence is largely derived from expert opinion and limited retrospective studies. By evaluating the severity of esophagitis in relation to antacid therapy, the study hopes to provide clearer insights into effective management strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are children with repaired esophageal atresia who are undergoing surveillance endoscopy at Boston Children's Hospital.
Not a fit: Patients with jejunal or colonic interpositions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for managing esophagitis in children with repaired esophageal atresia.
How similar studies have performed: While there is limited controlled research on this specific approach, the study builds on existing guidelines and aims to fill gaps in the current understanding of esophagitis management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All repaired esophageal atresia patients with primary esophageal anastomosis treated at Boston Children's Hospital are eligible to enroll before or at year-1 surveillance endoscopy Exclusion Criteria: * Patients with jejunal or colonic interpositions
Where this trial is running
Boston, Massachusetts and 1 other locations
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
- Boston Childrens Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Michael Manfredi, MD
- Email: michael.manfredi@childrens.harvard.edu
- Phone: 617-355-3038
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.