NCT05847101

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
26 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

May 6, 2023

Status Verified

April 1, 2023

Enrollment Period

10 months

First QC Date

April 7, 2023

Last Update Submit

May 4, 2023

Conditions

Tracheo Esophageal Fistula

Outcome Measures

Primary Outcomes (1)

  • Affection of tracheo-esophageal fistula in neanates

    evaluate factors affecting outcome of neonates with tracheoesophageal fistula.

    Baseline

Interventions

Tracheoesophageal fistula repairPROCEDURE

Tracheoesophageal fistula repair

Eligibility Criteria

AgeUp to 28 Days
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All newborn admitted to NICU with tracheoesophageal fistula.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 29050090BACKGROUND

  • 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.

    PMID: 26898863BACKGROUND

MeSH Terms

Conditions

Tracheoesophageal Fistula

Condition Hierarchy (Ancestors)

Esophageal FistulaDigestive System FistulaDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesRespiratory Tract FistulaRespiratory Tract DiseasesTracheal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Assem Abd Elrazek, doctor

CONTACT

+201222886620assemabdelrazek857@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

April 7, 2023

First Posted

May 6, 2023

Study Start

June 1, 2023

Primary Completion

April 1, 2024

Study Completion

May 1, 2024

Last Updated

May 6, 2023

Record last verified: 2023-04