Diaphragmatic HerniaCDH-EANCT02466451
Study in Children With the Diagnosis of Congenital Diaphragmatic Hernia (CDH) and Oesophageal Atresia (EA)
An observational study of Diaphragmatic Hernia and Oesophageal Atresia, run by Stefania La Grutta, MD.
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. Read more about this study
- Who is it for?
- Ages 5 months to 12 years
- Conditions the study is for
- Diaphragmatic Hernia, Oesophageal Atresia
- What is being tested?
- Questionnaires
- Type of treatment
- Pill or oral medicine
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 months to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: 33 Children operated at birth on diaphragmatic hernia and/or oesophageal atresia (age range : 5 months - 12 years old)
Who may be able to join
- Children operated at birth on diaphragmatic hernia and/or oesophageal atresia
- Written informed consent, signed by parents
Who cannot join
- Children that have had infections in the last 4 weeks
- Children with ongoing diseases
- Children that take drugs able to modify the lung function
About this study
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
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.
Read the 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)
- Conditions
- Diaphragmatic Hernia, Oesophageal Atresia
- Being tested
- Questionnaires
- Medical subject headings
- Hernia, Diaphragmatic, Esophageal Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Also called Standardized 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)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Function Test
Spirometry
Measured: 1 year
Secondary outcomes (1)
Quality of Life
QoL Questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startMar 2014
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragmatic HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stefania La Grutta, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stefania La Grutta, MD, Istituto per la Ricerca e l'Innovazione Biomedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466451
- Sponsor's protocol ID
- 5/2012
- Acronym
- CDH-EA
- Status last verified
- Mar 2016
- First submitted
- 12 May 2015
- Last updated
- 14 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02466451
- Acronym / sponsor ID
- CDH-EA / 5/2012
- Conditions
- Diaphragmatic Hernia, Oesophageal Atresia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Stefania La Grutta, MDUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 9 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children operated at birth on CDH and EA | – | Other: QuestionnairesStandardized 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). |
Who may qualify
- Ages
- 5 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 33 Children operated at birth on diaphragmatic hernia and/or oesophageal atresia (age range : 5 months - 12 years old)
Key inclusion criteria (2 listed)
- Children operated at birth on diaphragmatic hernia and/or oesophageal atresia
- Written informed consent, signed by parents
Key exclusion criteria (3 listed)
- Children that have had infections in the last 4 weeks
- Children with ongoing diseases
- Children that take drugs able to modify the lung function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesAlso: Standardized QuestionnairesFor 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 | Children operated at birth on CDH and EA |
Primary outcome
Pulmonary Function Test
Time frame: 1 year
Spirometry
1 secondary outcome
Quality of Life
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
Related trials for Diaphragmatic Hernia
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Fetoscopic Endoluminal Tracheal Occlusion in Severe Left Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia
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Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH
Pulmonary Hypertension of Newborn, Diaphragm Defect
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GORE® ENFORM Biomaterial Product Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diaphragmatic Hernia and Oesophageal Atresia, run by Stefania La Grutta, MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Function Test (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2016.