Outcome Predictors of Trachea-esophageal Fistula

Not yet recruiting

• Conditions: Tracheo Esophageal Fistula

• Registration Number: NCT05847101
• Lead Sponsor: Assiut University

Brief Summary

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

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 Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-04-07
• Study First Submitted QC: 2023-05-04
• Last Update Submitted: 2023-05-04
• Study First Posted: 2023-05-06
• Last Update Posted: 2023-05-06
• Study Start: 2023-06
• Primary Completion: 2024-04
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Affection of tracheo-esophageal fistula in neanates	Baseline	evaluate factors affecting outcome of neonates with tracheoesophageal fistula.