Outcome Predictors of Trachea-esophageal Fistula

May 4, 2023 updated by: Assem Abd El-razek Elkateeb, Assiut University

Outcome Predictors of Trachea-esophageal Fistula in Neonates Admitted to AUCH

In the present study, the investigator aim to evaluate the prevalence, factors affecting outcome and the outcome of neonates with tracheoesophageal fistula.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Tracheoesophageal fistula is a connection between the esophagus and the trachea.

Tracheoesophageal fistula (TEF) represents one of the most common congenital anomalies seen in infants, Infants with TEF classically present with respiratory distress, feeding difficulties, choking, and risk for aspiration. TEF is most commonly associated with other congenital anomalies, particularly cardiac defects. Esophageal atresia (EA) is a related congenital malformation with a similar presentation to TEF and can occur with or without the presence of a fistula.

Although the events leading to separation of the primitive trachea and esophagus are not completely understood, the most commonly accepted hypothesis is that a defect in the lateral septation of the foregut into the trachea and esophagus causes TEF and EA.

The trachea and esophagus develop from a common primitive foregut, and at approximately 4 weeks of gestation, the developing respiratory and gastrointestinal tracts are separated by epithelial ridges. The foregut divides into a ventral respiratory tract and a dorsal esophageal tract; the fistula tract is thought to derive from an embryonic lung bud that fails to undergo branching. These defects of mesenchymal proliferation are thought to lead to TEF formation.

The incidence of TEF is approximately 1 in 3500 births. EA and TEF are classified according to their anatomic configuration.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All newborn admitted to NICU with tracheoesophageal fistula.

Description

Inclusion Criteria:

  • Patients diagnosed with tracheoesophageal fistula are/below the age of 28 days.

Exclusion Criteria:

  • Patients above the age of 28 days.
  • Patients diagnosed with other diseases.
  • Patients with acquired tracheoesophageal fistula.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Affection of tracheo-esophageal fistula in neanates
Time Frame: Baseline
evaluate factors affecting outcome of neonates with tracheoesophageal fistula.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2023

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

April 7, 2023

First Submitted That Met QC Criteria

May 4, 2023

First Posted (Estimate)

May 8, 2023

Study Record Updates

Last Update Posted (Estimate)

May 8, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • trachea-esophageal fistula

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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