Clinical Trial: Study in Children With the Diagnosis of Congenital Diaphragmatic Hernia (CDH) and Oesophageal Atresia (EA)

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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 Li

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 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.

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)

Sponsor: Stefania La Grutta, MD

Current Primary Outcome: Pulmonary Function Test [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Quality of Life [ Time Frame: 1 year ]

Original Secondary Outcome: Same as current

Information By: Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy

Dates:
Date Received: May 12, 2015
Date Started: March 2014
Date Completion:
Last Updated: March 11, 2016
Last Verified: March 2016