Clinical trial NCT03767673: Cardiorespiratory Performance and Pulmonary Microbiome in Patients After Repair of Esophageal Atresia
Official title: Examination of the Cardiorespiratory Performance Capacity and Pulmonary Microbiome in Patients Following Surgical Repair of Esophageal Atresia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Atresia
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Pulmonary microbiome (16S rDNA profiling) - Alpha diversity
timeFrame: 1 year
measure: Pulmonary microbiome (16S rDNA profiling) - Beta diversity
timeFrame: 1 year
measure: Pulmonary microbiome (16S rDNA profiling) - relative bacterial abundance
timeFrame: 1 year
Secondary outcomes:
measure: Maximum oxygen uptake (ergospirometer)
timeFrame: 1 year
measure: Maximum Performance (ergospirometer)
timeFrame: 1 year
measure: Vital capacity (spirometry)
timeFrame: 1 year
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
affiliation: Department of Paediatric and Adolescent Surgery, Medical University of Graz, Austria
name: Jana Windhaber, MD
role: STUDY_DIRECTOR
affiliation: Department of Paediatric and Adolescent Surgery, Medical University of Graz, Austria
name: Holger Till, MD
role: STUDY_CHAIR
affiliation: Department of Paediatric and Adolescent Surgery, Medical University of Graz, Austria
name: Christoph Arneitz, MD
role: PRINCIPAL_INVESTIGATOR
References: