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

Medical University of Graz

Status: Unknown

Conditions: Esophageal Atresia

Treatments: Diagnostic Test: weight; Diagnostic Test: Pulmonary microbiome (16S rDNA profiling); Diagnostic Test: Initial Spirometry; Diagnostic Test: Maximum performance; Diagnostic Test: Final Spirometry; Diagnostic Test: Maximum oxygen uptake; Other: age

Study type: Interventional

Funder types: Other

Identifiers

NCT03767673

1.1

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Patients after esophageal atresia

Experimental group

Description:

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).

Treatment:

Diagnostic Test: Initial Spirometry

Diagnostic Test: Maximum performance

Diagnostic Test: Maximum oxygen uptake

Diagnostic Test: Pulmonary microbiome (16S rDNA profiling)

Diagnostic Test: weight

Other: age

Diagnostic Test: Final Spirometry

Control group

Active Comparator group

Description:

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).

Treatment:

Diagnostic Test: Initial Spirometry

Diagnostic Test: Maximum performance

Diagnostic Test: Maximum oxygen uptake

Diagnostic Test: Pulmonary microbiome (16S rDNA profiling)

Diagnostic Test: weight

Other: age

Diagnostic Test: Final Spirometry