Tracheo Esophageal FistulaNCT05847101
Outcome Predictors of Trachea-esophageal Fistula
An observational study of Tracheo Esophageal Fistula, run by Assiut University.
Trial summary
In the present study, the investigator aim to evaluate the prevalence, factors affecting outcome and the outcome of neonates with tracheoesophageal fistula. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Tracheo Esophageal Fistula
- What is being tested?
- Tracheoesophageal fistula repair
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 28 days
- All sexes
- Child
Study population: All newborn admitted to NICU with tracheoesophageal fistula.
Who may be able to join
- Patients diagnosed with tracheoesophageal fistula are/below the age of 28 days.
Who cannot join
- Patients above the age of 28 days.
- Patients diagnosed with other diseases.
- Patients with acquired tracheoesophageal fistula.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Tracheo Esophageal Fistula
- Being tested
- Tracheoesophageal fistula repair
- Medical subject headings
- Tracheoesophageal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracheoesophageal fistula repairProcedure or surgery
Tracheoesophageal fistula repair
What is being measured
The primary outcome is the main question the study is designed to answer.
Affection of tracheo-esophageal fistula in neanates
evaluate factors affecting outcome of neonates with tracheoesophageal fistula.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study startJun 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tracheo Esophageal FistulaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assem Abd El-razek Elkateeb, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847101
- Sponsor's protocol ID
- trachea-esophageal fistula
- Status last verified
- Apr 2023
- First submitted
- 7 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29050090Cui 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.
PubMed 26898863
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Predictors of Trachea-esophageal Fistula in Neonates Admitted to AUCH
- ClinicalTrials.gov ID
- NCT05847101
- Acronym / sponsor ID
- trachea-esophageal fistula
- Conditions
- Tracheo Esophageal Fistula
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Age groups
- Child
- Study population
- All newborn admitted to NICU with tracheoesophageal fistula.
Key inclusion criteria (1 listed)
- Patients diagnosed with tracheoesophageal fistula are/below the age of 28 days.
Key exclusion criteria (3 listed)
- Patients above the age of 28 days.
- Patients diagnosed with other diseases.
- Patients with acquired tracheoesophageal fistula.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tracheoesophageal fistula repairTracheoesophageal fistula repair | Procedure or surgery | – |
Primary outcome
Affection of tracheo-esophageal fistula in neanates
Time frame: Baseline
evaluate factors affecting outcome of neonates with tracheoesophageal fistula.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Background: PubMed 29050090Ma 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.
- Background: PubMed 26898863Cui 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheo Esophageal Fistula, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Assem Abd Elrazek, doctor (+201222886620, assemabdelrazek857@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Affection of tracheo-esophageal fistula in neanates (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05847101, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.