Study in Children With the Diagnosis of Congenital Diaphragmatic Hernia (CDH) and Oesophageal Atresia (EA)
- Conditions
- Oesophageal AtresiaDiaphragmatic Hernia
- Registration Number
- NCT02466451
- Lead Sponsor
- Stefania La Grutta, MD
- Brief Summary
Observational longitudinal study in children operated at birth on diaphragmatic hernia and/or oesophageal atresia : assessment of lung function parameters; assessment of quality of life and cognitive development; assessment of stress parenting and strategies of adaptation.
- Detailed Description
Observational longitudinal study in children operated at birth on diaphragmatic hernia and/or oesophageal atresia : assessment of lung function parameters; assessment of quality of life and cognitive development; assessment of stress parenting and strategies of adaptation.
Tools: Anamnestic-clinical questionnaire, Spirometry, Plethysmography, Fractional exhaled nitric oxide (FeNO) assessment (oral and alveolar ), 6-minutes walk test (WT 6'), Prick tests, Quality of life in children questionnaire(KINDL, quality of life), Psychological test for cognitive development (Raven Matrices)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- Children operated at birth on diaphragmatic hernia and/or oesophageal atresia
- Written informed consent, signed by parents
- Children that have had infections in the last 4 weeks
- Children with ongoing diseases
- Children that take drugs able to modify the lung function
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pulmonary Function Test 1 year Spirometry
- Secondary Outcome Measures
Name Time Method Quality of Life 1 year QoL Questionnaire