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

Stefania La Grutta, MD

Status: Completed

Conditions: Oesophageal Atresia; Diaphragmatic Hernia

Treatments: Other: Questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT02466451

5/2012

Details and patient eligibility

About

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.

Full 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)

Enrollment: 33 patients

Sex: All

Ages: 5 months to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

33 participants in 1 patient group

Children operated at birth on CDH and EA

Description:

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).

Treatment:

Other: Questionnaires