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

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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02466451

Acronym

CDH-EA

Enrollment

Registered

2015-06-09

Start date

2014-03-31

Completion date

2015-05-31

Last updated

2016-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diaphragmatic Hernia, Oesophageal Atresia

Brief summary

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)

Interventions

OTHERQuestionnaires

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)

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Months to 12 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Pulmonary Function Test	1 year	Spirometry

Secondary

Measure	Time frame	Description
Quality of Life	1 year	QoL Questionnaire

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026