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Cardiorespiratory Performance and Pulmonary Microbiome in Patients After Repair of Esophageal Atresia

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ClinicalTrials.gov Identifier: NCT03767673
Recruitment Status : Recruiting
First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Esophageal Atresia 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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Control group: Age and sex matched healthy volunteers.
Primary Purpose: Diagnostic
Official Title: Examination of the Cardiorespiratory Performance Capacity and Pulmonary Microbiome in Patients Following Surgical Repair of Esophageal Atresia
Actual Study Start Date : August 10, 2017
Estimated Primary Completion Date : April 6, 2019
Estimated Study Completion Date : September 2, 2019


Arm Intervention/treatment
Experimental: Patients after esophageal atresia
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).
Diagnostic Test: Initial Spirometry
Determination of Vital Capacity by spirometry before (within 30 minutes) spiroergometry. Measurements will be performed in both groups.

Diagnostic Test: Final Spirometry
Determination of Vital Capacity by spirometry after (within 30 minutes) spiroergometry. Measurements will be performed in both groups.

Diagnostic Test: 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: Maximum oxygen uptake
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.

Diagnostic Test: Maximum performance
Determination of the maximum performance (W/kg) corrected for body weight by bicycle spiroergometry. Measurements will be performed in both groups.

Diagnostic Test: weight
Determined by Kilogram on a medical weight scale

Other: age
Determination of age by patient's Report and past medical history

Active Comparator: Control group
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).
Diagnostic Test: Initial Spirometry
Determination of Vital Capacity by spirometry before (within 30 minutes) spiroergometry. Measurements will be performed in both groups.

Diagnostic Test: Final Spirometry
Determination of Vital Capacity by spirometry after (within 30 minutes) spiroergometry. Measurements will be performed in both groups.

Diagnostic Test: 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: Maximum oxygen uptake
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.

Diagnostic Test: Maximum performance
Determination of the maximum performance (W/kg) corrected for body weight by bicycle spiroergometry. Measurements will be performed in both groups.

Diagnostic Test: weight
Determined by Kilogram on a medical weight scale

Other: age
Determination of age by patient's Report and past medical history




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Maximum oxygen uptake (ergospirometer) [ Time Frame: 1 year ]
    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.

  2. Maximum Performance (ergospirometer) [ Time Frame: 1 year ]
    Maximum performance as determined by bicycle ergospirometer. Comparison of parameters between patients after repair of esophageal atresia and age and sex matched healthy controls.

  3. Vital capacity (spirometry) [ Time Frame: 1 year ]
    Vital capacity as determined by spirometry. Comparison of parameters between patients after repair of esophageal atresia and age and sex matched healthy controls.



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age from 12 years
  • Status post surgical correction of esophageal atresia with and without fistula
  • Granted consent

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03767673


Contacts
Contact: Jana Windhaber, MD. 01143316358 ext 83770 jana.windhaber@klinikum-graz.at
Contact: Christoph Arneitz, MD. 01143316358 ext 80358 christoph.arneitz@gmail.com

Locations
Austria
Medical University of Graz Recruiting
Graz, Austria, 8010
Contact: Jana Windhaber, MD    01143316385 ext 83770    jana.windhaber@medunigraz.at   
Contact: Christoph Arneitz, MD    01143316385 ext 80358    christoph.arneitz@gmail.com   
Sponsors and Collaborators
Medical University of Graz
Investigators
Study Director: Jana Windhaber, MD Department of Paediatric and Adolescent Surgery, Medical University of Graz, Austria
Study Chair: Holger Till, MD Department of Paediatric and Adolescent Surgery, Medical University of Graz, Austria
Principal Investigator: Christoph Arneitz, MD Department of Paediatric and Adolescent Surgery, Medical University of Graz, Austria

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT03767673     History of Changes
Other Study ID Numbers: 1.1
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Esophageal Atresia
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Congenital Abnormalities