Outcome Predictors of Trachea-esophageal Fistula

Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Tracheoesophageal fistula repair

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 Design

Study Type:
Anticipated Enrollment :
100 participants
Observational Model:
Time Perspective:
Official Title:
Outcome Predictors of Trachea-esophageal Fistula in Neonates Admitted to AUCH
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Affection of tracheo-esophageal fistula in neanates [Baseline]

    evaluate factors affecting outcome of neonates with tracheoesophageal fistula.

Eligibility Criteria


Ages Eligible for Study:
N/A to 28 Days
Sexes Eligible for Study:
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.

Contacts and Locations


No locations specified.

Sponsors and Collaborators

  • Assiut University


None specified.

Study Documents (Full-Text)

None provided.

More Information


Responsible Party:
Assem Abd El-razek Elkateeb, Doctor, Assiut University
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • trachea-esophageal fistula
First Posted:
May 6, 2023
Last Update Posted:
May 6, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2023