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

Diaphragmatic Hernia Clinical Trial

— CDH-EA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02466451
• Other study ID #: 5/2012
• Status: Completed
• Phase: N/A
• First received: May 12, 2015
• Last updated: March 11, 2016
• Start date: March 2014
• Est. completion date: May 2015

Study information

• Verified date: March 2016
• Source: Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Bioethics Committee
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Months to 12 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diaphragmatic Hernia
• Esophageal Atresia
• Hernia
• Hernia, Diaphragmatic
• Oesophageal Atresia

Intervention

Other:
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stefania La Grutta, MD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary Function Test	Spirometry	1 year	No
Secondary	Quality of Life	QoL Questionnaire	1 year	No