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

Esophageal Atresia Clinical Trial

Official title:

Examination of the Cardiorespiratory Performance Capacity and Pulmonary Microbiome in Patients Following Surgical Repair of Esophageal Atresia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03767673
• Other study ID #: 1.1
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2017
• Est. completion date: September 2, 2019

Study information

• Verified date: December 2018
• Source: Medical University of Graz
• Contact: Jana Windhaber, MD.
• Phone: 01143316358
• Email: jana.windhaber[@]klinikum-graz.at
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2, 2019
• Est. primary completion date: April 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Atresia

Intervention

Diagnostic Test:
• Initial Spirometry
Determination of Vital Capacity by spirometry before (within 30 minutes) spiroergometry. Measurements will be performed in both groups.
• Final Spirometry
Determination of Vital Capacity by spirometry after (within 30 minutes) spiroergometry. Measurements will be performed in both groups.
• 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).
• 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.
• Maximum performance
Determination of the maximum performance (W/kg) corrected for body weight by bicycle spiroergometry. Measurements will be performed in both groups.
• weight
Determined by Kilogram on a medical weight scale

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

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Primary	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.	1 year
Primary	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 year