Observational Longitudinal Study in Children With the Diagnosis of Diaphragmatic Hernia and/or Oesophageal Atresia for Assessing Lung Function Parameters and Quality of Life
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Diaphragmatic Hernia
- Sponsor
- Stefania La Grutta, MD
- Enrollment
- 33
- Primary Endpoint
- Pulmonary Function Test
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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)
Investigators
Stefania La Grutta, MD
Senior Researcher
Istituto per la Ricerca e l'Innovazione Biomedica
Eligibility Criteria
Inclusion Criteria
- •Children operated at birth on diaphragmatic hernia and/or oesophageal atresia
- •Written informed consent, signed by parents
Exclusion Criteria
- •Children that have had infections in the last 4 weeks
- •Children with ongoing diseases
- •Children that take drugs able to modify the lung function
Outcomes
Primary Outcomes
Pulmonary Function Test
Time Frame: 1 year
Spirometry
Secondary Outcomes
- Quality of Life(1 year)