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Management of Esophagitis Following Repair of Esophageal Atresia

NCT03619408 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2021-09-10

No results posted yet for this study

Summary

The goal of this study is to prospectively evaluate the impact of antacid therapy on esophagitis in children with repaired esophageal atresia. Recent clinical guidelines have attempted to define a systematic approach to the management of these patients with regards to minimizing and treating esophagitis (Krishnan et al 2016), however the quality of evidence supporting many of the recommendations are based on expert opinion or on limited, retrospective studies. Risk factors for esophagitis and optimal length of antacid therapy are not well defined. Through this study, we aim to identify risk factors for the presence of esophagitis in patients with repaired esophageal atresia. We hypothesize that antacid therapy improves esophagitis severity in children following esophageal repair.

Conditions

  • Esophageal Atresia
  • Esophagitis

Interventions

DRUG

Antacids

Omeprazole 1 mg/kg/dose BID or Omeprazole 1mg/kg/dose BID plus Ranitidine 3 mg/kg/dose BID

Sponsors & Collaborators

Eligibility

Min Age
30 Days
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2025-07-31
Completion
2025-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03619408 on ClinicalTrials.gov