An observational study in Esophageal Atresia and Healthy Children, sponsored by Hacettepe University. Recruiting at 1 site in Turkey. Open to participants aged 6 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-29.
Sponsored by Hacettepe University · Observational
Esophageal atresia is the most common congenital anomaly of the esophagus and is caused by abnormal development of the esophagus during intrauterine life. In children with esophageal atresia, structural abnormalities due to congenital anomalies and tracheoesophageal fistula, tracheomalacia, respiratory problems, recurrent respiratory tract infections, structural abnormalities, surgical interventions for repair and treatment, and decreased physical activity levels may negatively affect pulmonary function, effective coughing, muscle strength, exercise capacity, posture, motor function, and quality of life. This study aims to compare physical characteristics, body composition, pulmonary function and muscle strength, peak cough flow, posture assessment, peripheral muscle strength test, motor function, exercise capacity, physical activity level, fatigue, frailty and quality of life between children with esophageal atresia and their healthy peers.
37 studies on the registry are indexed under Esophageal Atresia; 12 are open to participants now.
This study's planned enrollment of 20 is below the median of 50 across 19 observational studies indexed under Esophageal Atresia.
Browse Esophageal Atresia studies →Hacettepe University is the lead sponsor of 1,007 studies on the registry; 214 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children with esophageal atresia and their healthy peers
Esophageal atresia group
Inclusion Criteria:
Exclusion Criteria:
Control group
Inclusion Criteria:
Exclusion Criteria:
Children with esophageal atresia
Other: No intervention
Healthy children
Other: No intervention
No intervention
Forced vital capacity
Pulmonary function test using a spirometer will be performed. Forced vital capacity will be recorded.
Time frame: 1st day
Forced expiratory volume in one second
Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second will be recorded.
Time frame: 1st day
Forced expiratory volume in one second/forced vital capacity ratio
Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second/forced vital capacity ratio will be recorded.
Time frame: 1st day
Peak expiratory flow
Pulmonary function test using a spirometer will be performed. Peak expiratory flow will be recorded.
Time frame: 1st day
Forced mid-expiratory flow
Pulmonary function test using a spirometer will be performed. Forced mid-expiratory flow (FEF25-75) will be recorded.
Time frame: 1st day
Body composition
Body composition will be evaluated by triceps skinfold thickness. Skinfold caliper will be used to evaluate triceps skinfold thickness.
Time frame: 1st day
Maximal inspiratory pressure
Maximal inspiratory pressure will be measured using an mouthpiece pressure measuring device.
Time frame: 1st day
Maximal expiratory pressure
Maximal expiratory pressure will be measured using an mouthpiece pressure measuring device.
Time frame: 1st day
Peak cough flow
Peak cough flow will be measured using a peak flow meter.
Time frame: 1st day
Hand grip strength
Hand grip strength will be evaluated with a hand dynamometer device.
Time frame: 1st day
Knee extensor muscle strength
Knee extensor muscle strength will be assessed with a portable digital dynamometer.
Time frame: 1st day
Shoulder abductor muscle strength
Shoulder abductor muscle strength will be assessed with a portable digital dynamometer.
Time frame: 1st day
Motor function
Motor function will be assessed using Time Up and Go test. In the Time Up and Go test, the individual is asked to stand up from a standard chair with armrests, walk 3 m, turn, walk back to the chair, and sit down again. The time is recorded in seconds.
Time frame: 1st day
Functional exercise capacity
6 minute walk test will be performed to assess functional capacity.
Time frame: 1st day
Physical activity level
The Physical Activity Questionnaire for Children (PAQ-C) and the Physical Activity Questionnaire for Adolescents (PAQ-A) will be used to assess physical activity levels. The Turkish versions of these assessment tools have been shown to be valid and reliable. The total score ranges from 1 to 5, where 1 indicates very low physical activity, 5 indicates very high physical activity levels.
Time frame: 1st day
Exercise capacity
To assess exercise capacity, a symptom-limited cardiopulmonary exercise test will be performed on a bicycle ergometer using Bruce protocol.
Time frame: 1 week after other assessments
Frailty
Frailty level will be calculated using the Composite Frailty Score: (1) Slowness: 6 minute walk test, (2) Weakness: handgrip strength, (3) Fatigue: Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale (PedsQL-MFS), (4) Body composition: triceps skinfold thickness, and (5) Physical activity questionnaire. Each domain is scored on a 0-5 point scale, using z-scores or raw questionnaire scores to assign frailty points (0 = least frail, 5 = most frail). The five domain scores is summed to generate a Composite Frailty Score ranging from 0 to 25, where higher scores reflect greater frailty.
Time frame: 1st day
Quality of life assessment
Quality of life will be assessed using Esophageal-Atresia-Quality of Life (EA-QOL) questionnaire. The EA-QOL questionnaire consist of a 17-item parent-reported questionnaire for children aged 2-7 years (eating, physical health and treatment, social isolation, and stress) and a 24-item questionnaire available as child- and parent-reported versions for children aged 8-17 years (eating, social relationships, body image, and health and well-being). Scores range from 0 to 100. Higher scores indicate better quality of life.
Time frame: 1st day
Fatigue
Fatigue will be assessed using the Pediatric Quality of Life Multidimensional Fatigue Scale (PedsQL-MFS). The PedsQL-MFS allows the child to assess their own fatigue and parents to assess their child's fatigue. The higher the score, the better the quality of life, indicating fewer fatigue symptoms. Therefore, a score of "0" on the PedsQL-MFS indicates greater fatigue, while a score of "100" indicates less fatigue.
Time frame: 1st day
Corbin Posture Rating Scale
Corbin Posture Rating Scale and observational posture analysis. It is an assessment consisting of lateral and posterior posture analysis. '0' is excellent, 12 and above indicates poor posture.
Time frame: 1st day
Plan to share: No
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Started Oct 2024 (actual). Primary completion is estimated for Oct 2027, 36 months after the start.
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