Outcome Predictors of Trachea-esophageal Fistula

Tracheo Esophageal Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05847101
• Other study ID #: trachea-esophageal fistula
• Status: Not yet recruiting
• Start date: June 2023
• Est. completion date: May 2024

Study information

• Verified date: April 2023
• Source: Assiut University
• Contact: Assem Abd Elrazek, doctor
• Phone: +201222886620
• Email: assemabdelrazek857[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 2024
• Est. primary completion date: April 2024
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Fistula
• Fistula
• Tracheo Esophageal Fistula
• Tracheoesophageal Fistula

Intervention

Procedure:
• Tracheoesophageal fistula repair
Tracheoesophageal fistula repair

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

Cui PC, Luo JS, Liu Z, Bian K, Guo ZH, Ma RN. [Segmental tracheal resection and anastomosis for the treatment of cicatricial stenosis in cervical tracheal]. Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2016 Feb;51(2):95-9. doi: 10.3760/cma.j.issn.1673-0860.2016.02.004. Chinese. — View Citation

Ma LJ, Xiao Y, Yang QW, Wang J. [Laryngotracheal resection and reconstruction for the treatment of acquired laryngotracheal stenosis]. Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2017 Oct 7;52(10):738-743. doi: 10.3760/cma.j.issn.1673-0860.2017.10.005. Chinese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Affection of tracheo-esophageal fistula in neanates	evaluate factors affecting outcome of neonates with tracheoesophageal fistula.	Baseline