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

Completed

• Conditions: Oesophageal Atresia; Diaphragmatic Hernia
• Interventions: Other: Questionnaires

• Registration Number: NCT02466451
• Lead Sponsor: Stefania La Grutta, MD

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)

Study Timeline

• Study Start: 2014-03
• Primary Completion: 2015-04
• Study Completion: 2015-05
• Study First Submitted: 2015-05-12
• Study First Submitted QC: 2015-06-05
• Study First Posted: 2015-06-09
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-11
• Last Update Posted: 2016-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children operated at birth on CDH and EA	Questionnaires	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).

Primary Outcome Measures

Name	Time	Method
Pulmonary Function Test	1 year	Spirometry

Secondary Outcome Measures

Name	Time	Method
Quality of Life	1 year	QoL Questionnaire