Recruiting

Esophagitis Management

Sponsor:

Boston Children's Hospital

Code:

NCT03619408

Conditions

Esophageal Atresia

Esophagitis

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Antacids

Study Details

Brief 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

Study ID

NCT03619408

Start date

Feb 1, 2019

Status verified date

Sep, 2021

Completion date

Jul, 2025

Anticipated

Primary completion date

Jul, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

No/Mild Esophagitis

All repaired esophageal atresia patients at Boston Children's Hospital with primary esophageal anastomosis undergoing routine year-1 surveillance endoscopy / pH-impedance studies found to have no or mild histologic esophagitis, no erosive esophagitis, and reflux index <3% on pH-metry. Antacid therapy will be discontinued.

Moderate/Severe Esophagitis

All repaired esophageal atresia patients at Boston Children's Hospital with primary esophageal anastomosis undergoing routine year-1 surveillance endoscopy / pH-impedance studies found to have moderate or severe histologic esophagitis, and/or erosive esophagitis, and/or reflux index > 3% on pH-metry.

Antacid therapy with PPI (omeprazole 1mg/kg/dose BID) will be initiated. For patients already taking PPI at therapeutic dosing, an H2 blocker (ranitidine 3mg/kg/dose BID) will be added.

Interventions

Antacids

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

Primary outcome measure

  • Esophagitis [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Michael Manfredi, MD

617-355-3038michael.manfredi@childrens.harvard.edu

Jessica Yasuda, MD

617-355-3038jessica.yasuda@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Boston Childrens Hospital

Recruiting

Boston, Massachusetts, United States, 02115

More Information

Sponsor

Boston Children's Hospital

Last update posted

Sep 10, 2021

Last verified

Sep, 2021

Keywords

  • Esophageal Atresia
  • Esophagitis
  • GER
  • Gastroesopheal reflux
  • PPI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2021-09-10.