Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-03 @ 8:40 PM
Study NCT ID:
NCT02466451
Status:
COMPLETED
Last Update Posted:
2016-03-14
First Post:
2015-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study in Children With the Diagnosis of Congenital Diaphragmatic Hernia (CDH) and Oesophageal Atresia (EA)
Sponsor:
Stefania La Grutta, MD
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CDH-EA
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)
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)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: