Esophageal Atresia
Conditions
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.
Interventions
DIAGNOSTIC_TESTInitial Spirometry
Determination of Vital Capacity by spirometry before (within 30 minutes) spiroergometry. Measurements will be performed in both groups.
DIAGNOSTIC_TESTFinal Spirometry
Determination of Vital Capacity by spirometry after (within 30 minutes) spiroergometry. Measurements will be performed in both groups.
DIAGNOSTIC_TESTPulmonary 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_TESTMaximum 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_TESTMaximum performance
Determination of the maximum performance (W/kg) corrected for body weight by bicycle spiroergometry. Measurements will be performed in both groups.
DIAGNOSTIC_TESTweight
Determined by Kilogram on a medical weight scale
OTHERage
Determination of age by patient's Report and past medical history
Sponsors
Medical University of Graz
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Control group: Age and sex matched healthy volunteers.
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Austria
Contacts
Primary ContactJana Windhaber, MD.
Backup ContactChristoph Arneitz, MD.
Outcome results
None listed