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

NCT02466451 | Completed

• 1 other identifier: 5/2012
• Study Type: observational
• Target: 33
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diaphragmatic Hernia; Oesophageal Atresia

Outcome Measures

Primary Outcomes (1)

• Pulmonary Function Test

  Spirometry

  1 year

Secondary Outcomes (1)

• Quality of Life

  1 year

Study Arms (1)

Children operated at birth on CDH and EA

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).

Other: Questionnaires

Interventions

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)

Also known as: Standardized Questionnaires

Children operated at birth on CDH and EA

Eligibility Criteria

• Age: 5 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

33 Children operated at birth on diaphragmatic hernia and/or oesophageal atresia (age range : 5 months - 12 years old)

You may qualify if:

• Children operated at birth on diaphragmatic hernia and/or oesophageal atresia
• Written informed consent, signed by parents

You may not qualify if:

• Children that have had infections in the last 4 weeks
• Children with ongoing diseases
• Children that take drugs able to modify the lung function

Sponsors & Collaborators

• Stefania La Grutta, MD: lead

MeSH Terms

Conditions

Hernia, Diaphragmatic; Esophageal Atresia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: May 12, 2015
• First Posted: June 9, 2015
• Study Start: March 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2015
• Last Updated: March 14, 2016

Record last verified: 2016-03