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

Not Applicable

• Conditions: Esophageal Atresia

• Registration Number: NCT03767673
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-10
• Study First Submitted: 2018-07-19
• Status Verified: 2018-12
• Study First Submitted QC: 2018-12-05
• Last Update Submitted: 2018-12-05
• Study First Posted: 2018-12-06
• Last Update Posted: 2018-12-06
• Primary Completion: 2019-04-06
• Study Completion: 2019-09-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pulmonary microbiome (16S rDNA profiling) - Alpha diversity	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	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	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

Name	Time	Method
Maximum oxygen uptake (ergospirometer)	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.
Maximum Performance (ergospirometer)	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.
Vital capacity (spirometry)	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.

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Austria