Esophageal AtresiaNCT03767673
Cardiorespiratory Performance and Pulmonary Microbiome in Patients After Repair of Esophageal Atresia
A study testing Initial Spirometry, Final Spirometry and Pulmonary microbiome (16S rDNA profiling) in people with Esophageal Atresia, run by Medical University of Graz at 1 site in Austria.
Trial summary
The majority of the clinical research on esophageal atresia focuses on the upper gastrointestinal tract. However, the trachea and the lung are also affected in many of these children, so that a lifelong pulmonary impairment may result. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Esophageal Atresia
- What is being tested?
- Initial Spirometry, Final Spirometry and Pulmonary microbiome (16S rDNA profiling)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 10 Aug 2017to 2 Sep 2019
- Phase
- Interventional
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age from 12 years
- Status post surgical correction of esophageal atresia with and without fistula
- Granted consent
Who cannot join
- Acute infections within the last 14 days
- Other associated serious malformations
- Acute, temporary respiratory complaints (cough, allergies etc.)
- Physical and mental illnesses or disabilities that do not allow the examination to be carried out
- non-granted consent
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Graz
Graz, 8010
Jana Windhaber, MD, 01143316385 ext. 83770, jana.windhaber@medunigraz.at
Christoph Arneitz, MD, 01143316385 ext. 80358, christoph.arneitz@gmail.com
About this study
Official title: Examination of the Cardiorespiratory Performance Capacity and Pulmonary Microbiome in Patients Following Surgical Repair of Esophageal Atresia
The majority of the clinical research on esophageal atresia focuses on the upper gastrointestinal tract. However, the trachea and the lung are also affected in many of these children, so that a lifelong pulmonary impairment may result. The importance of respiratory function in the context of follow-up of these patients has therefore been increasingly recognized in recent years. Scientific work has shown significantly, that patients following esophageal atresia repair develop respiratory symptoms more frequently than the normal population. Mild impairment of the pulmonary function in adolescence and adulthood was demonstrated in some studies, but to date, there is no exact idea about the relationship between early childhood disease progression and later pulmonary impairment. Only a few scientific papers have dealt with the effect of impaired pulmonary function on the physical capacity of these adolescents and adults. Most of these studies show small case numbers, inconclusive stress tests, and divergent results.
The aim of this prospective study is to investigate the cardiopulmonary performance capacity and the pulmonary microbiome of adolescent and adult patients with corrected esophageal atresia and to compare the results with a control group. Another focus of the investigators is on the composition of the pulmonary microbiome of the participants. Changes of the pulmonary microbiome and the influence on the cardio-pulmonary performance capacity have not yet been investigated. Furthermore, it should be investigated whether the treatment measures and a complicated disease course in the neonatal period have long-term effects on lung function, exercise capacity and composition of the microbiome in the lungs.
- Conditions
- Esophageal Atresia
- Being tested
- Initial Spirometry, Final Spirometry, Pulmonary microbiome (16S rDNA profiling), Maximum oxygen uptake, Maximum performance
- Medical subject headings
- Esophageal Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial SpirometryDiagnostic test
Determination of Vital Capacity by spirometry before (within 30 minutes) spiroergometry. Measurements will be performed in both groups.
Final SpirometryDiagnostic test
Determination of Vital Capacity by spirometry after (within 30 minutes) spiroergometry. Measurements will be performed in both groups.
Pulmonary microbiome (16S rDNA profiling)Diagnostic test
Harvesting of deep induced sputum and determination of the airway microbiome by 16S ribosomal RNA (rRNA) pyrosequencing. Evaluation of alpha and beta diversity and relative bacterial abundance at the genus level. Measurements will be performed in both groups (samples will be harvested within 30 minutes after spiroergometry).
Maximum oxygen uptakeDiagnostic test
Determination of the maximum oxygen uptake (ml/kg/min) corrected for gender, age and body weight by bicycle spiroergometry. Measurements will be performed in both groups.
Maximum performanceDiagnostic test
Determination of the maximum performance (W/kg) corrected for body weight by bicycle spiroergometry. Measurements will be performed in both groups.
weightDiagnostic test
Determined by Kilogram on a medical weight scale
ageOther
Determination of age by patient's Report and past medical history
| Study group | Role | What they receive |
|---|---|---|
| Patients after esophageal atresia | Experimental | Patients older than 12 years following surgical repair of congenital esophageal atresia will be included after written informed consent. Patients will be subjected to spirometry to determine their age, weight (determined by Kilogram (kg) on a medical weight scale) and Vital Capacity before (initial Spirometry) and after (final Spirometry) exercise performance testing. Bicycle ergospirometer will be applied to determine the Maximum Oxygen Uptake and the Maximum Performance. Thereafter deep induced sputum will be harvested for measurements of the pulmonary microbiome (Pulmonary Microbiome 16S rDNA profiling). Receives: Diagnostic Test: Initial Spirometry; Diagnostic Test: Final Spirometry; Diagnostic Test: Pulmonary microbiome (16S rDNA profiling); Diagnostic Test: Maximum oxygen uptake; Diagnostic Test: Maximum performance; Diagnostic Test: weight; Other: age |
| Control group | Active comparator | Age and sex matched adolescents will be recruited as control group and will be included after written informed consent. Adolescents will be subjected to spirometry to determine their age, weight (determined by Kilogram on a medical weight scale) and Vital Capacity before (initial Spirometry) and after (final Spirometry) exercise performance testing. Bicycle ergospirometer will be applied to determine the Maximum Oxygen Uptake and the Maximum Performance. Thereafter deep induced sputum will be harvested for measurements of the pulmonary microbiome (Pulmonary Microbiome 16S rDNA profiling). Receives: Diagnostic Test: Initial Spirometry; Diagnostic Test: Final Spirometry; Diagnostic Test: Pulmonary microbiome (16S rDNA profiling); Diagnostic Test: Maximum oxygen uptake; Diagnostic Test: Maximum performance; Diagnostic Test: weight; Other: age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary microbiome (16S rDNA profiling) - Alpha diversity
Determination of alpha diversity (Chao1 Test) at the genus level of deep induced Sputum by 16S rDNA profiling. Comparison of Alpha diversity (Chao1 Analysis) between patients after repair of esophageal atresia and age and sex matched healthy controls.
Measured: 1 year
Pulmonary microbiome (16S rDNA profiling) - Beta diversity
Determination of beta diversity (unweighted UniFrac test) at the genus level of deep induced Sputum by 16S rDNA profiling. Comparison of beta-diversity (Unweighted UniFrac Analysis) between patients after repair of esophageal atresia and age and sex matched healthy controls.
Measured: 1 year
Pulmonary microbiome (16S rDNA profiling) - relative bacterial abundance
Determination of relative bacterial abundance (in per Cent) at the genus level of deep induced Sputum by 16S rDNA profiling. Comparison of relative bacterial abundance (Mann-Whitney-U-Test) between patients after repair of esophageal atresia and age and sex matched healthy controls.
Measured: 1 year
Secondary outcomes (3)
Maximum oxygen uptake (ergospirometer)
Maximum oxygen uptake (corrected for age, gender and body weight ) as determined by bicycle ergospirometer. Comparison of parameters between patients after repair of esophageal atresia and age and sex matched healthy controls.
Measured: 1 year
Maximum Performance (ergospirometer)
Maximum performance as determined by bicycle ergospirometer. Comparison of parameters between patients after repair of esophageal atresia and age and sex matched healthy controls.
Measured: 1 year
Vital capacity (spirometry)
Vital capacity as determined by spirometry. Comparison of parameters between patients after repair of esophageal atresia and age and sex matched healthy controls.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start10 Aug 2017
- Primary completion6 Apr 2019 (estimated)
- Study completion2 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal AtresiaStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jana Windhaber, MD, Study director, Department of Paediatric and Adolescent Surgery, Medical University of Graz, AustriaHolger Till, MD, Study chair, Department of Paediatric and Adolescent Surgery, Medical University of Graz, AustriaChristoph Arneitz, MD, Principal investigator, Department of Paediatric and Adolescent Surgery, Medical University of Graz, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767673
- Sponsor's protocol ID
- 1.1
- Status last verified
- Dec 2018
- First submitted
- 19 Jul 2018
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Cardiorespiratory Performance Capacity and Pulmonary Microbiome in Patients Following Surgical Repair of Esophageal Atresia
- ClinicalTrials.gov ID
- NCT03767673
- Acronym / sponsor ID
- 1.1
- Conditions
- Esophageal Atresia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 6 Apr 2019 (estimated)
- Study completion
- 2 Sep 2019 (estimated)
- First posted
- 6 Dec 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 majority of the clinical research on esophageal atresia focuses on the upper gastrointestinal tract. However, the trachea and the lung are also affected in many of these children, so that a lifelong pulmonary impairment may result. The importance of respiratory function in the context of follow-up of these patients has therefore been increasingly recognized in recent years. Scientific work has shown significantly, that patients following esophageal atresia repair develop respiratory symptoms more frequently than the normal population. Mild impairment of the pulmonary function in adolescence and adulthood was demonstrated in some studies, but to date, there is no exact idea about the relationship between early childhood disease progression and later pulmonary impairment. Only a few scientific papers have dealt with the effect of impaired pulmonary function on the physical capacity of these adolescents and adults. Most of these studies show small case numbers, inconclusive stress tests, and divergent results.
The aim of this prospective study is to investigate the cardiopulmonary performance capacity and the pulmonary microbiome of adolescent and adult patients with corrected esophageal atresia and to compare the results with a control group. Another focus of the investigators is on the composition of the pulmonary microbiome of the participants. Changes of the pulmonary microbiome and the influence on the cardio-pulmonary performance capacity have not yet been investigated. Furthermore, it should be investigated whether the treatment measures and a complicated disease course in the neonatal period have long-term effects on lung function, exercise capacity and composition of the microbiome in the lungs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients after esophageal atresia | Experimental | Diagnostic Test: Initial Spirometry, Diagnostic Test: Final Spirometry, Diagnostic Test: Pulmonary microbiome (16S rDNA profiling), Diagnostic Test: Maximum oxygen uptake, Diagnostic Test: Maximum performance, Diagnostic Test: weight, Other: agePatients older than 12 years following surgical repair of congenital esophageal atresia will be included after written informed consent. Patients will be subjected to spirometry to determine their age, weight (determined by Kilogram (kg) on a medical weight scale) and Vital Capacity before (initial Spirometry) and after (final Spirometry) exercise performance testing. Bicycle ergospirometer will be applied to determine the Maximum Oxygen Uptake and the Maximum Performance. Thereafter deep induced sputum will be harvested for measurements of the pulmonary microbiome (Pulmonary Microbiome 16S rDNA profiling). |
| Control group | Active comparator | Diagnostic Test: Initial Spirometry, Diagnostic Test: Final Spirometry, Diagnostic Test: Pulmonary microbiome (16S rDNA profiling), Diagnostic Test: Maximum oxygen uptake, Diagnostic Test: Maximum performance, Diagnostic Test: weight, Other: ageAge and sex matched adolescents will be recruited as control group and will be included after written informed consent. Adolescents will be subjected to spirometry to determine their age, weight (determined by Kilogram on a medical weight scale) and Vital Capacity before (initial Spirometry) and after (final Spirometry) exercise performance testing. Bicycle ergospirometer will be applied to determine the Maximum Oxygen Uptake and the Maximum Performance. Thereafter deep induced sputum will be harvested for measurements of the pulmonary microbiome (Pulmonary Microbiome 16S rDNA profiling). |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age from 12 years
- Status post surgical correction of esophageal atresia with and without fistula
- Granted consent
Key exclusion criteria (5 listed)
- Acute infections within the last 14 days
- Other associated serious malformations
- Acute, temporary respiratory complaints (cough, allergies etc.)
- Physical and mental illnesses or disabilities that do not allow the examination to be carried out
- non-granted consent
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 |
|---|---|---|
| Initial SpirometryDetermination of Vital Capacity by spirometry before (within 30 minutes) spiroergometry. Measurements will be performed in both groups. | Diagnostic test | Control group, Patients after esophageal atresia |
| Final SpirometryDetermination of Vital Capacity by spirometry after (within 30 minutes) spiroergometry. Measurements will be performed in both groups. | Diagnostic test | Control group, Patients after esophageal atresia |
| Pulmonary microbiome (16S rDNA profiling)Harvesting of deep induced sputum and determination of the airway microbiome by 16S ribosomal RNA (rRNA) pyrosequencing. Evaluation of alpha and beta diversity and relative bacterial abundance at the genus level. Measurements will be performed in both groups (samples will be harvested within 30 minutes after spiroergometry). | Diagnostic test | Control group, Patients after esophageal atresia |
| Maximum oxygen uptakeDetermination of the maximum oxygen uptake (ml/kg/min) corrected for gender, age and body weight by bicycle spiroergometry. Measurements will be performed in both groups. | Diagnostic test | Control group, Patients after esophageal atresia |
| Maximum performanceDetermination of the maximum performance (W/kg) corrected for body weight by bicycle spiroergometry. Measurements will be performed in both groups. | Diagnostic test | Control group, Patients after esophageal atresia |
| weightDetermined by Kilogram on a medical weight scale | Diagnostic test | Control group, Patients after esophageal atresia |
| ageDetermination of age by patient's Report and past medical history | Other | Control group, Patients after esophageal atresia |
Primary outcome
Pulmonary microbiome (16S rDNA profiling) - Alpha diversity
Time frame: 1 year
Determination of alpha diversity (Chao1 Test) at the genus level of deep induced Sputum by 16S rDNA profiling. Comparison of Alpha diversity (Chao1 Analysis) between patients after repair of esophageal atresia and age and sex matched healthy controls.
Pulmonary microbiome (16S rDNA profiling) - Beta diversity
Time frame: 1 year
Determination of beta diversity (unweighted UniFrac test) at the genus level of deep induced Sputum by 16S rDNA profiling. Comparison of beta-diversity (Unweighted UniFrac Analysis) between patients after repair of esophageal atresia and age and sex matched healthy controls.
Pulmonary microbiome (16S rDNA profiling) - relative bacterial abundance
Time frame: 1 year
Determination of relative bacterial abundance (in per Cent) at the genus level of deep induced Sputum by 16S rDNA profiling. Comparison of relative bacterial abundance (Mann-Whitney-U-Test) between patients after repair of esophageal atresia and age and sex matched healthy controls.
3 secondary outcomes
Maximum oxygen uptake (ergospirometer)
Time frame: 1 year
Maximum Performance (ergospirometer)
Time frame: 1 year
Vital capacity (spirometry)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
Related trials for Esophageal Atresia
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Camera-based Endoscopy Allows Spontaneous Breathing Diagnostic Management in Neonates With Tracheoesophageal Fistula
Tracheoesophageal Fistula, Esophageal Atresia With Tracheo-esophageal Fistula
Recruiting
Balloon Inflation Time for Esophageal Strictures (BITES): A Randomized Multi-Center Study
Esophageal Atresia With Tracheo-esophageal Fistula, Esophageal Atresia
RecruitingObservational study
Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence
Esophageal Atresia
Recruiting
Dumping Syndrome and Esophageal Atresia
Oesophageal Atresia, Dumping Syndrome
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.
Jana Windhaber, MD study director
Department of Paediatric and Adolescent Surgery, Medical University of Graz, Austria
Holger Till, MD study chair
Department of Paediatric and Adolescent Surgery, Medical University of Graz, Austria
Christoph Arneitz, MD principal investigator
Department of Paediatric and Adolescent Surgery, Medical University of Graz, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Initial Spirometry, Final Spirometry and Pulmonary microbiome (16S rDNA profiling) in people with Esophageal Atresia, run by Medical University of Graz at 1 site in Austria.
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 3 inclusion and 5 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 Dec 2018. 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 Austria. 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 Jana Windhaber, MD. (01143316358 ext. 83770, jana.windhaber@klinikum-graz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary microbiome (16S rDNA profiling) - Alpha diversity (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2018.