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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.1 years study duration

Study Start

First participant enrolled

August 10, 2017

Completed

11 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2018

Completed

5 months until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed

4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2019

Completed

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2019

Completed

Last Updated

December 6, 2018

Status Verified

December 1, 2018

Enrollment Period

1.7 years

First QC Date

July 19, 2018

Last Update Submit

December 5, 2018

Conditions

Esophageal Atresia

Outcome Measures

Primary Outcomes (3)

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
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
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 Outcomes (3)

Maximum oxygen uptake (ergospirometer)
1 year
Maximum Performance (ergospirometer)
1 year
Vital capacity (spirometry)
1 year

Study Arms (2)

Patients after esophageal atresia

EXPERIMENTAL

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).

Diagnostic Test: Initial SpirometryDiagnostic Test: Final SpirometryDiagnostic Test: Pulmonary microbiome (16S rDNA profiling)Diagnostic Test: Maximum oxygen uptakeDiagnostic Test: Maximum performanceDiagnostic Test: weightOther: age

Control group

ACTIVE COMPARATOR

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).

Interventions

Initial SpirometryDIAGNOSTIC_TEST

Determination of Vital Capacity by spirometry before (within 30 minutes) spiroergometry. Measurements will be performed in both groups.