Management of Esophagitis Following Repair of Esophageal Atresia

NCT03619408 | Unknown FDA Drug

• 1 other identifier: P00029371
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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

Keywords

Esophageal Atresia; Esophagitis; GER; Gastroesopheal reflux; PPI

Outcome Measures

Primary Outcomes (1)

• Esophagitis

  Histologic esophagitis score graded as none, mild, moderate or severe

  2 years

Secondary Outcomes (3)

• Esophagitis (macroscopic)

  2 years

• Barrett's esophagus

  2 years

• Hospitalizations

  2 years

Study Arms (2)

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.

Drug: Antacids

Interventions

Antacids DRUG

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

Moderate/Severe Esophagitis

Eligibility Criteria

• Age: 30 Days - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Pediatric esophageal atresia patients with primary esophageal anastomosis at Boston Children's Hospital

You may qualify if:

• 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

You may not qualify if:

• Patients with jejunal or colonic interpositions

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (2)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Boston Childrens Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (3)

• Krishnan U, Mousa H, Dall'Oglio L, Homaira N, Rosen R, Faure C, Gottrand F. ESPGHAN-NASPGHAN Guidelines for the Evaluation and Treatment of Gastrointestinal and Nutritional Complications in Children With Esophageal Atresia-Tracheoesophageal Fistula. J Pediatr Gastroenterol Nutr. 2016 Nov;63(5):550-570. doi: 10.1097/MPG.0000000000001401.

  PMID: 27579697 BACKGROUND

• Miyake H, Chen Y, Hock A, Seo S, Koike Y, Pierro A. Are prophylactic anti-reflux medications effective after esophageal atresia repair? Systematic review and meta-analysis. Pediatr Surg Int. 2018 May;34(5):491-497. doi: 10.1007/s00383-018-4242-4. Epub 2018 Mar 13.

  PMID: 29536176 BACKGROUND

• Pinheiro PF, Simoes e Silva AC, Pereira RM. Current knowledge on esophageal atresia. World J Gastroenterol. 2012 Jul 28;18(28):3662-72. doi: 10.3748/wjg.v18.i28.3662.

  PMID: 22851858 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

esophageal biopsies obtained with cold forceps during routine surveillance endoscopies

MeSH Terms

Conditions

Esophageal Atresia; Esophagitis

Interventions

Antacids

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gastroenteritis

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Gastrointestinal Agents; Therapeutic Uses

Central Study Contacts

Michael Manfredi, MD

CONTACT

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

Jessica Yasuda, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics, Harvard Medical School

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 7, 2018
• Study Start: February 1, 2019
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: September 10, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)