Trials / Completed
CompletedNCT02466451
Study in Children With the Diagnosis of Congenital Diaphragmatic Hernia (CDH) and Oesophageal Atresia (EA)
Observational Longitudinal Study in Children With the Diagnosis of Diaphragmatic Hernia and/or Oesophageal Atresia for Assessing Lung Function Parameters and Quality of Life
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 33 (actual)
- Sponsor
- Stefania La Grutta, MD · Academic / Other
- Sex
- All
- Age
- 5 Months – 12 Years
- Healthy volunteers
- Not accepted
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Questionnaires | For not collaborative patients, under the age of 4 years: * Standardized questionnaire collecting anamnestic-clinical data * Stress Parenting Index questionnaire and COPE brief questionnaire(Questionnaire assessing adaptation strategies of parents). For collaborative patients, over the age of 4 years: * Standardized questionnaire collecting anamnestic-clinical data * Fractional exhaled nitric oxide (FeNO) assessment (oral and alveolar ) * Spirometry * 6-minutes walk test (WT 6') * Prick tests * Children Quality of life questionnaire (KINDL questionnaire) * Psychological test (Raven Matrices) * Stress Parenting Index questionnaire and COPE brief questionnaire (Questionnaire assessing adaptation strategies of parents) |
Timeline
- Start date
- 2014-03-01
- Primary completion
- 2015-04-01
- Completion
- 2015-05-01
- First posted
- 2015-06-09
- Last updated
- 2016-03-14
Source: ClinicalTrials.gov record NCT02466451. Inclusion in this directory is not an endorsement.