Study in Children With the Diagnosis of Congenital Diaphragmatic Hernia (CDH) and Oesophageal Atresia (EA)
NCT ID: NCT02466451
Last Updated: 2016-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
33 participants
OBSERVATIONAL
2014-03-31
2015-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Children operated at birth on CDH and EA
Standardized Questionnaires:For not collaborative patients,\< 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, \>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).
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)
Interventions
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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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written informed consent, signed by parents
Exclusion Criteria
* Children with ongoing diseases
* Children that take drugs able to modify the lung function
5 Months
12 Years
ALL
No
Sponsors
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Stefania La Grutta, MD
OTHER
Responsible Party
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Stefania La Grutta, MD
Senior Researcher
Other Identifiers
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5/2012
Identifier Type: -
Identifier Source: org_study_id
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