Tracheoesophageal FistulaTEDNCT03455881
Phenotypic and Genetic Assessment of Tracheal and Esophageal Birth Defects in Patients
An observational study of Tracheoesophageal Fistula and Esophageal Atresia, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The investigators propose a preliminary study performing exome sequencing on samples from patients and their biologically related family members with tracheal and esophageal birth defects (TED). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tracheoesophageal Fistula, Esophageal Atresia, Laryngeal Cleft
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2018to Jan 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Approximately 100 NICU TED patient/parent trios for the NICU TED Genetic cohort. Approximately 100 NICU TED patients for the NICU TED MRI cohort. These patients will also be in the NICU TED cohort. Approximately 155 TED patient/parent trios from the Esophageal Center for the Esophageal Center Genetic cohort. Approximately 5 NICU infants with normal tracheal and esophageal anatomy for the NICU Control MRI cohort.
Who may be able to join
- Patient that has been diagnosed by clinical team with a congenital TED OR family member to the TED diagnosed patient.
- Willingness to donate biological specimens.
- Ability to consent/assent as appropriate.
- Infant born between 24 and 42 weeks PMA.
- TED diagnosed by clinical team.
- Inpatient in the Neonatal Intensive Care Unit (NICU) OR family member to the inpatient in the NICU.
Show all 18Show fewer
- Willingness to donate biological specimens.
- Ability to consent/assent as appropriate.
- Infant born between 24 and 42 weeks PMA.
- TED diagnosed by clinical team.
- Inpatient in the CCHMC (Cincinnati Children's Hospital Medical Center) NICU.
- Clinically stable and adequate temperature control to tolerate MRI as determined by the primary clinical team.
- Infant and biological parents are participating in the NICU TED cohort.
- Ability to consent/assent as appropriate.
- Infant born between 24 and 42 weeks post menstrual age (PMA).
- No tracheal or esophageal defects.
- Inpatient in the CCHMC NICU.
- Clinically stable and adequate temperature control to tolerate MRI as determined by the primary clinical team.
Who cannot join
- Unable to determine or unavailable parent trio.
- Unable to provide DNA sample.
- Inability to provide consent.
- NICU TED Genetic Cohort:
- Unable to determine or unavailable parent trio.
- Unable to provide DNA sample.
Show all 17Show fewer
- Inability to provide consent.
- NICU TED MRI Cohort:
- Infant is on extracorporeal membrane oxygenation (ECMO).
- Evidence of congenital diseases that may affect ability to tolerate MRI.
- Standard MRI exclusion criteria as set forth by the CCHMC Department of Radiology. This includes any contraindications from tracheostomy tubes that are not MR compatible.
- Inability to provide consent.
- NICU Control MRI Cohort:
- Infant is on ECMO.
- Evidence of congenital diseases that may affect ability to tolerate MRI.
- Standard MRI exclusion criteria as set forth by the CCHMC Department of Radiology. This includes any contraindications from tracheostomy tubes that are not MR compatible.
- Inability to provide consent.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Paul Kingma, MD, PhD, 513-636-2995, paul.kingma@cchmc.org
Paul Kingma, MD, PhD
About this study
Official title: Comprehensive Phenotypic and Genetic Assessment of Tracheal and Esophageal Birth Defects in Patients
The investigators propose a preliminary study performing exome sequencing on samples from patients and their biologically related family members with tracheal and esophageal birth defects (TED). The purpose of this study is to determine if patients diagnosed with TED and similar disorders carry distinct mutations that lead to predisposition.
The investigators will use advanced, non-invasive magnetic resonance imaging (MRI) techniques to assess tracheal esophageal, lung, and cardiac morphology and function in Neonatal Intensive Care Unit (NICU) patients. MRI techniques is done exclusively if patient is clinically treated at primary study location and if patient has not yet had their initial esophageal repair.
Read the detailed description
TEDs (tracheal esophageal birth defects) are a life threatening congenital disorder with multiple long term complications. Occurring in 1 in 2,500 to 4,500 live births, TEDs include tracheal malformations such as tracheomalacia, laryngotracheoesophageal clefts, tracheal agenesis, tracheal stenosis, tracheal bronchus, esophageal bronchus and esophageal malformations such as esophageal atresia (EA), tracheal esophageal fistula (TEF), and esophageal duplication. TEDs likely have a genetic basis, but in most cases the specific mutations are unknown. The most commonly diagnosed TED, requiring neonatal hospitalization, is EA/TEF. The familial recurrence rate of EA/TEF is 1% suggesting many result from de novo mutations and while environmental factors may have a minor influence, the mechanisms are unclear. The investigators hypothesize that patients diagnosed with TED and similar disorders carry distinct mutations that lead to predisposition. Currently the diagnosis is confirmed only with a plain chest x-ray showing a coiled feeding tube within the upper esophageal pouch. This approach does not determine the anatomic subtype of EA/TEF, the number or location of TEFs, the size of the gap between proximal and distal esophagus, or the presence of tracheomalacia. Many have evaluated preoperative laryngotracheo-bronchoscopy (LTB) and others have evaluated preoperative computerized tomography (CT) scanning to decrease the unknown factors associated with x-ray, but despite their potential benefits, they have great drawbacks. Therefore, there is a compelling need to develop noninvasive non ionizing imaging methods to evaluate TED infants. Magnetic Resonance Imaging (MRI) is an ideal candidate to fill this role in that it provides non-invasive high resolution anatomic and functional information. Here the investigators propose a preliminary study performing exome sequencing on samples from these patients and their biologically related family members. The investigators will also use advanced, non-invasive MR imaging techniques to assess TE, lung, and cardiac morphology and function in NICU patients.
- Conditions
- Tracheoesophageal Fistula, Esophageal Atresia, Laryngeal Cleft, Tracheal Stenosis, Bronchial Stenosis, Esophageal Bronchus
- Keywords
- TEF, EA, Tracheal Esophageal birth Defect (TED)
- Medical subject headings
- Tracheoesophageal Fistula, Esophageal Atresia, Laryngeal cleft, Tracheal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NICU TED Genetic Cohort | This study involves one inpatient biofluid collection encounter from the subject, one biofluid collection encounter from each biological parent, and an optional biofluid collection encounter from other biological family members. | |
| NICU TED MRI Cohort | This study involves up to three inpatient NICU MRI encounters. The first MRI may be done before surgical repair if the clinical team feels the infant is clinically stable. The second MRI may be completed post-surgical repair of TED. An additional 3rd MRI may be done prior to the time of discharge from the NICU. The pre repair, post-surgical, and pre discharge MRIs will provide valuable data for the understanding of tracheal esophageal malformation disorders and may provide clinical guidance for the participant's care. | |
| TED Genetic Cohort | This study involves one biofluid collection encounter from the subject, one biofluid collection encounter from each biological parent, and an optional biofluid collection encounter from other biological family members. | |
| NICU Control MRI Cohort | This study involves two inpatient NICU MRI encounters. The first MRI will occur within the first month of life, and the second MRI will occur prior to discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genomic Sequencing
Identify novel genes and mutations in patients with TEDs using trio genomic sequencing of TED patients and their parents.
Measured: 1 day
Anatomic phenotypes using MRI
Investigate the esophageal, tracheal, mediastinal and pulmonary anatomy in patients with TEDs.
Measured: 1 day
Secondary outcomes (1)
Change in the anatomic phenotype using MRI
Investigate the esophageal, tracheal, mediastinal and pulmonary anatomy in patients with TEDs before and after surgical repair.
Measured: Change in MRI from pre-repair to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start28 Mar 2018
- Primary completionJan 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Tracheoesophageal FistulaStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Columbia University
- Responsible party
- Sponsor
- Investigators
- Paul Kingma, MD, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455881
- Sponsor's protocol ID
- CIN_PhenoandGeneticTED_001
- Other IDs
- 1P01HD093363-01
- Acronym
- TED
- Status last verified
- Mar 2023
- First submitted
- 12 Feb 2018
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brosens E, Ploeg M, van Bever Y, Koopmans AE, IJsselstijn H, Rottier RJ, Wijnen R, Tibboel D, de Klein A. Clinical and etiological heterogeneity in patients with tracheo-esophageal malformations and associated anomalies. Eur J Med Genet. 2014 Aug;57(8):440-52. doi: 10.1016/j.ejmg.2014.05.009. Epub 2014 Jun 13.
PubMed 24931924Sfeir R, Michaud L, Salleron J, Gottrand F. Epidemiology of esophageal atresia. Dis Esophagus. 2013 May-Jun;26(4):354-5. doi: 10.1111/dote.12051.
PubMed 23679022Sfeir R, Michaud L, Sharma D, Richard F, Gottrand F. National Esophageal Atresia Register. Eur J Pediatr Surg. 2015 Dec;25(6):497-9. doi: 10.1055/s-0035-1569466. Epub 2015 Dec 7.
PubMed 26642387McMullen KP, Karnes PS, Moir CR, Michels VV. Familial recurrence of tracheoesophageal fistula and associated malformations. Am J Med Genet. 1996 Jun 28;63(4):525-8. doi: 10.1002/(SICI)1096-8628(19960628)63:43.0.CO;2-N.
PubMed 8826429Oddsberg J, Jia C, Nilsson E, Ye W, Lagergren J. Influence of maternal parity, age, and ethnicity on risk of esophageal atresia in the infant in a population-based study. J Pediatr Surg. 2008 Sep;43(9):1660-5. doi: 10.1016/j.jpedsurg.2007.11.021.
PubMed 18779003Parolini F, Boroni G, Stefini S, Agapiti C, Bazzana T, Alberti D. Role of preoperative tracheobronchoscopy in newborns with esophageal atresia: A review. World J Gastrointest Endosc. 2014 Oct 16;6(10):482-7. doi: 10.4253/wjge.v6.i10.482.
PubMed 25324919Zani A, Eaton S, Hoellwarth ME, Puri P, Tovar J, Fasching G, Bagolan P, Lukac M, Wijnen R, Kuebler JF, Cecchetto G, Rintala R, Pierro A. International survey on the management of esophageal atresia. Eur J Pediatr Surg. 2014 Feb;24(1):3-8. doi: 10.1055/s-0033-1350058. Epub 2013 Aug 9.
PubMed 23934626Lal D, Miyano G, Juang D, Sharp NE, St Peter SD. Current patterns of practice and technique in the repair of esophageal atresia and tracheoesophageal fistua: an IPEG survey. J Laparoendosc Adv Surg Tech A. 2013 Jul;23(7):635-8. doi: 10.1089/lap.2013.0210. Epub 2013 Jun 12.
PubMed 23758564Sharma N, Srinivas M. Laryngotracheobronchoscopy prior to esophageal atresia and tracheoesophageal fistula repair--its use and importance. J Pediatr Surg. 2014 Feb;49(2):367-9. doi: 10.1016/j.jpedsurg.2013.09.009.
PubMed 24528988Atzori P, Iacobelli BD, Bottero S, Spirydakis J, Laviani R, Trucchi A, Braguglia A, Bagolan P. Preoperative tracheobronchoscopy in newborns with esophageal atresia: does it matter? J Pediatr Surg. 2006 Jun;41(6):1054-7. doi: 10.1016/j.jpedsurg.2006.01.074.
PubMed 16769333Pigna A, Gentili A, Landuzzi V, Lima M, Baroncini S. Bronchoscopy in newborns with esophageal atresia. Pediatr Med Chir. 2002 Jul-Aug;24(4):297-301.
PubMed 12197089Mahalik SK, Sodhi KS, Narasimhan KL, Rao KL. Role of preoperative 3D CT reconstruction for evaluation of patients with esophageal atresia and tracheoesophageal fistula. Pediatr Surg Int. 2012 Oct;28(10):961-6. doi: 10.1007/s00383-012-3111-9. Epub 2012 Jun 22.
PubMed 22722826Ngerncham M, Lee EY, Zurakowski D, Tracy DA, Jennings R. Tracheobronchomalacia in pediatric patients with esophageal atresia: comparison of diagnostic laryngoscopy/bronchoscopy and dynamic airway multidetector computed tomography. J Pediatr Surg. 2015 Mar;50(3):402-7. doi: 10.1016/j.jpedsurg.2014.08.021. Epub 2014 Oct 1.
PubMed 25746697Pedersen RN, Calzolari E, Husby S, Garne E; EUROCAT Working group. Oesophageal atresia: prevalence, prenatal diagnosis and associated anomalies in 23 European regions. Arch Dis Child. 2012 Mar;97(3):227-32. doi: 10.1136/archdischild-2011-300597. Epub 2012 Jan 13.
PubMed 22247246Teague WJ, Karpelowsky J. Surgical management of oesophageal atresia. Paediatr Respir Rev. 2016 Jun;19:10-5. doi: 10.1016/j.prrv.2016.04.003. Epub 2016 Apr 21.
PubMed 27217220
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Phenotypic and Genetic Assessment of Tracheal and Esophageal Birth Defects in Patients
- ClinicalTrials.gov ID
- NCT03455881
- Acronym / sponsor ID
- TED / CIN_PhenoandGeneticTED_001
- Conditions
- Tracheoesophageal Fistula, Esophageal Atresia, Laryngeal Cleft, Tracheal Stenosis, Bronchial Stenosis, Esophageal Bronchus
- Keywords
- TEF, EA, Tracheal Esophageal birth Defect (TED)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Columbia University
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 7 Mar 2018 (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.
The investigators propose a preliminary study performing exome sequencing on samples from patients and their biologically related family members with tracheal and esophageal birth defects (TED). The purpose of this study is to determine if patients diagnosed with TED and similar disorders carry distinct mutations that lead to predisposition.
The investigators will use advanced, non-invasive magnetic resonance imaging (MRI) techniques to assess tracheal esophageal, lung, and cardiac morphology and function in Neonatal Intensive Care Unit (NICU) patients. MRI techniques is done exclusively if patient is clinically treated at primary study location and if patient has not yet had their initial esophageal repair.
Detailed description
TEDs (tracheal esophageal birth defects) are a life threatening congenital disorder with multiple long term complications. Occurring in 1 in 2,500 to 4,500 live births, TEDs include tracheal malformations such as tracheomalacia, laryngotracheoesophageal clefts, tracheal agenesis, tracheal stenosis, tracheal bronchus, esophageal bronchus and esophageal malformations such as esophageal atresia (EA), tracheal esophageal fistula (TEF), and esophageal duplication. TEDs likely have a genetic basis, but in most cases the specific mutations are unknown. The most commonly diagnosed TED, requiring neonatal hospitalization, is EA/TEF. The familial recurrence rate of EA/TEF is 1% suggesting many result from de novo mutations and while environmental factors may have a minor influence, the mechanisms are unclear. The investigators hypothesize that patients diagnosed with TED and similar disorders carry distinct mutations that lead to predisposition. Currently the diagnosis is confirmed only with a plain chest x-ray showing a coiled feeding tube within the upper esophageal pouch. This approach does not determine the anatomic subtype of EA/TEF, the number or location of TEFs, the size of the gap between proximal and distal esophagus, or the presence of tracheomalacia. Many have evaluated preoperative laryngotracheo-bronchoscopy (LTB) and others have evaluated preoperative computerized tomography (CT) scanning to decrease the unknown factors associated with x-ray, but despite their potential benefits, they have great drawbacks. Therefore, there is a compelling need to develop noninvasive non ionizing imaging methods to evaluate TED infants. Magnetic Resonance Imaging (MRI) is an ideal candidate to fill this role in that it provides non-invasive high resolution anatomic and functional information. Here the investigators propose a preliminary study performing exome sequencing on samples from these patients and their biologically related family members. The investigators will also use advanced, non-invasive MR imaging techniques to assess TE, lung, and cardiac morphology and function in NICU patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NICU TED Genetic Cohort | – | –This study involves one inpatient biofluid collection encounter from the subject, one biofluid collection encounter from each biological parent, and an optional biofluid collection encounter from other biological family members. |
| NICU TED MRI Cohort | – | –This study involves up to three inpatient NICU MRI encounters. The first MRI may be done before surgical repair if the clinical team feels the infant is clinically stable. The second MRI may be completed post-surgical repair of TED. An additional 3rd MRI may be done prior to the time of discharge from the NICU. The pre repair, post-surgical, and pre discharge MRIs will provide valuable data for the understanding of tracheal esophageal malformation disorders and may provide clinical guidance for the participant's care. |
| TED Genetic Cohort | – | –This study involves one biofluid collection encounter from the subject, one biofluid collection encounter from each biological parent, and an optional biofluid collection encounter from other biological family members. |
| NICU Control MRI Cohort | – | –This study involves two inpatient NICU MRI encounters. The first MRI will occur within the first month of life, and the second MRI will occur prior to discharge. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Approximately 100 NICU TED patient/parent trios for the NICU TED Genetic cohort. Approximately 100 NICU TED patients for the NICU TED MRI cohort. These patients will also be in the NICU TED cohort. Approximately 155 TED patient/parent trios from the Esophageal Center for the Esophageal Center Genetic cohort. Approximately 5 NICU infants with normal tracheal and esophageal anatomy for the NICU Control MRI cohort.
Key inclusion criteria (18 listed)
- Patient that has been diagnosed by clinical team with a congenital TED OR family member to the TED diagnosed patient.
- Willingness to donate biological specimens.
- Ability to consent/assent as appropriate.
- Infant born between 24 and 42 weeks PMA.
- TED diagnosed by clinical team.
Key exclusion criteria (17 listed)
- Unable to determine or unavailable parent trio.
- Unable to provide DNA sample.
- Inability to provide consent.
- Unable to determine or unavailable parent trio.
- Unable to provide DNA sample.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Genomic Sequencing
Time frame: 1 day
Identify novel genes and mutations in patients with TEDs using trio genomic sequencing of TED patients and their parents.
Anatomic phenotypes using MRI
Time frame: 1 day
Investigate the esophageal, tracheal, mediastinal and pulmonary anatomy in patients with TEDs.
1 secondary outcome
Change in the anatomic phenotype using MRI
Time frame: Change in MRI from pre-repair to discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Background: PubMed 24931924Brosens E, Ploeg M, van Bever Y, Koopmans AE, IJsselstijn H, Rottier RJ, Wijnen R, Tibboel D, de Klein A. Clinical and etiological heterogeneity in patients with tracheo-esophageal malformations and associated anomalies. Eur J Med Genet. 2014 Aug;57(8):440-52. doi: 10.1016/j.ejmg.2014.05.009. Epub 2014 Jun 13.
- Background: PubMed 23679022Sfeir R, Michaud L, Salleron J, Gottrand F. Epidemiology of esophageal atresia. Dis Esophagus. 2013 May-Jun;26(4):354-5. doi: 10.1111/dote.12051.
- Background: PubMed 26642387Sfeir R, Michaud L, Sharma D, Richard F, Gottrand F. National Esophageal Atresia Register. Eur J Pediatr Surg. 2015 Dec;25(6):497-9. doi: 10.1055/s-0035-1569466. Epub 2015 Dec 7.
- Background: PubMed 8826429McMullen KP, Karnes PS, Moir CR, Michels VV. Familial recurrence of tracheoesophageal fistula and associated malformations. Am J Med Genet. 1996 Jun 28;63(4):525-8. doi: 10.1002/(SICI)1096-8628(19960628)63:43.0.CO;2-N.
- Background: PubMed 18779003Oddsberg J, Jia C, Nilsson E, Ye W, Lagergren J. Influence of maternal parity, age, and ethnicity on risk of esophageal atresia in the infant in a population-based study. J Pediatr Surg. 2008 Sep;43(9):1660-5. doi: 10.1016/j.jpedsurg.2007.11.021.
- Background: PubMed 25324919Parolini F, Boroni G, Stefini S, Agapiti C, Bazzana T, Alberti D. Role of preoperative tracheobronchoscopy in newborns with esophageal atresia: A review. World J Gastrointest Endosc. 2014 Oct 16;6(10):482-7. doi: 10.4253/wjge.v6.i10.482.
- Background: PubMed 23934626Zani A, Eaton S, Hoellwarth ME, Puri P, Tovar J, Fasching G, Bagolan P, Lukac M, Wijnen R, Kuebler JF, Cecchetto G, Rintala R, Pierro A. International survey on the management of esophageal atresia. Eur J Pediatr Surg. 2014 Feb;24(1):3-8. doi: 10.1055/s-0033-1350058. Epub 2013 Aug 9.
- Background: PubMed 23758564Lal D, Miyano G, Juang D, Sharp NE, St Peter SD. Current patterns of practice and technique in the repair of esophageal atresia and tracheoesophageal fistua: an IPEG survey. J Laparoendosc Adv Surg Tech A. 2013 Jul;23(7):635-8. doi: 10.1089/lap.2013.0210. Epub 2013 Jun 12.
- Background: PubMed 24528988Sharma N, Srinivas M. Laryngotracheobronchoscopy prior to esophageal atresia and tracheoesophageal fistula repair--its use and importance. J Pediatr Surg. 2014 Feb;49(2):367-9. doi: 10.1016/j.jpedsurg.2013.09.009.
- Background: PubMed 16769333Atzori P, Iacobelli BD, Bottero S, Spirydakis J, Laviani R, Trucchi A, Braguglia A, Bagolan P. Preoperative tracheobronchoscopy in newborns with esophageal atresia: does it matter? J Pediatr Surg. 2006 Jun;41(6):1054-7. doi: 10.1016/j.jpedsurg.2006.01.074.
- Background: PubMed 12197089Pigna A, Gentili A, Landuzzi V, Lima M, Baroncini S. Bronchoscopy in newborns with esophageal atresia. Pediatr Med Chir. 2002 Jul-Aug;24(4):297-301.
- Background: PubMed 22722826Mahalik SK, Sodhi KS, Narasimhan KL, Rao KL. Role of preoperative 3D CT reconstruction for evaluation of patients with esophageal atresia and tracheoesophageal fistula. Pediatr Surg Int. 2012 Oct;28(10):961-6. doi: 10.1007/s00383-012-3111-9. Epub 2012 Jun 22.
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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.
Paul Kingma, MD, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheoesophageal Fistula and Esophageal Atresia, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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 18 inclusion and 17 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 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Paul Kingma, MD, PhD ((513)636-2995, paul.kingma@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genomic Sequencing (time frame: 1 day). The study lists 2 primary outcomes in all. 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 NCT03455881, which also lists 19 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 8 Mar 2023.