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

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ClinicalTrials.gov Identifier: NCT02466451
Recruitment Status : Completed
First Posted : June 9, 2015
Last Update Posted : March 14, 2016
Sponsor:
Information provided by (Responsible Party):
Stefania La Grutta, MD, Istituto per la Ricerca e l'Innovazione Biomedica

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.

Condition or disease Intervention/treatment
Diaphragmatic Hernia Oesophageal Atresia Other: Questionnaires

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)


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Study Type : Observational
Actual Enrollment : 33 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Study Start Date : March 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : May 2015


Group/Cohort Intervention/treatment
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

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 Name: Standardized Questionnaires




Primary Outcome Measures :
  1. Pulmonary Function Test [ Time Frame: 1 year ]
    Spirometry


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 1 year ]
    QoL Questionnaire



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Ages Eligible for Study:   5 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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

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Responsible Party: Stefania La Grutta, MD, Senior Researcher, Istituto per la Ricerca e l'Innovazione Biomedica
ClinicalTrials.gov Identifier: NCT02466451     History of Changes
Other Study ID Numbers: 5/2012
First Posted: June 9, 2015    Key Record Dates
Last Update Posted: March 14, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Esophageal Atresia
Hernias, Diaphragmatic, Congenital
Hernia
Hernia, Diaphragmatic
Pathological Conditions, Anatomical
Congenital Abnormalities
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents