Study in Children With the Diagnosis of… | Clinical Trial

Key information

Conditions

Diaphragmatic Hernia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases Esophageal Atresia Esophageal Diseases Gastrointestinal Diseases Hernia Hernia, Diaphragmatic Internal Hernia Oesophageal Atresia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

5 month–12 year

Sex eligibility

All sexes

Study type

Observational

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

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)

Other names: Standardized Questionnaires

Primary outcomes

Pulmonary Function Test

Time frame: 1 year

Spirometry

Secondary outcomes

Quality of Life

Time frame: 1 year

QoL Questionnaire

Sponsors and collaborators

Lead sponsor

Stefania La Grutta, MD

Other

Registry information

Official study 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

Acronym: CDH-EA

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Jun 9, 2015
Registry last updated: Mar 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed