- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00373763
Fetoscopic Tracheal Balloon Occlusion in Unborns With Severe Congenital Diaphragmatic Hernia - EUROTRIAL I
August 22, 2008 updated by: University Hospital, Bonn
Randomized Clinical Trial for the Assessment of the Life-Saving Potential of Fetoscopic Tracheal Balloon Occlusion in Fetuses With Severe Congenital Diaphragmatic Hernia - EUROTRIAL I
Diaphragmatic hernia detected in fetal life carries a high risk for postnatal demise due to lung underdevelopment.
Clinical experience from prospective controlled non-randomized case series with fetoscopic tracheal balloon occlusion has seen improved survival rates in contrast to untreated controls.
Therefore, the purpose of this randomized clinical trial is to provide further evidence about the efficacy and safety of the prenatal interventional approach.
Primary outcome measure is postnatal survival to discharge from hospital treatment.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
98
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bonn, Germany, 53105
- German Center for Fetal Surgery & Minimally-Invasive Therapy-University of Bonn
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Mannheim, Germany, 68167
- Neonatal Intensive Care Unit (ECMO center), University of Mannheim
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Pregnant women from European countries carrying fetuses with congenital right or left diaphragmatic hernias
- Normal karyotype, no further severe anomalies on prenatal ultrasound study
- Fetal liver herniation into the chest, Lung-to-head ratio of ≥0,40 ≤0,84 between 30+0 - 33+5 weeks+days of gestation
Exclusion Criteria:
- Any maternal disease or condition that would result in an increased risk to her personal health from the experimental procedure
- Abnormal fetal karyotype
- Further severe fetal anomalies on prenatal ultrasound
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Survival to discharge from hospital
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Secondary Outcome Measures
Outcome Measure |
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Maternal morbidity
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Fetal morbidity
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Premature preterm rupture of membranes
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Unintended preterm delivery
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Conventional ventilation strategies possible
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ECMO required
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Days in intensive care
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Days in hospital
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Oxygen dependency on discharge
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
September 6, 2006
First Submitted That Met QC Criteria
September 6, 2006
First Posted (Estimate)
September 8, 2006
Study Record Updates
Last Update Posted (Estimate)
August 25, 2008
Last Update Submitted That Met QC Criteria
August 22, 2008
Last Verified
August 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DH-EUROTRIAL I - 093/06
- 093/06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Fetoscopic tracheal balloon occlusion
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Universitaire Ziekenhuizen KU LeuvenRecruitingCongenital Diaphragmatic HerniaBelgium
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-
University of Colorado, DenverRecruiting
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Alireza ShamshirsazNot yet recruitingCongenital Diaphragmatic HerniaUnited States
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Children's Hospitals and Clinics of MinnesotaAllina Health SystemRecruiting
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University Hospital, GasthuisbergThe University of Texas Health Science Center, Houston; Baylor College of Medicine and other collaboratorsCompletedCongenital Diaphragmatic Hernia | Pulmonary Hypoplasia | Fetal SurgeryUnited Kingdom, Canada, United States, Belgium, Germany, Italy, France, Australia, Poland, Spain
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University Hospital, GasthuisbergThe University of Texas Health Science Center, Houston; Hospital Clinic of... and other collaboratorsCompletedCongenital Diseases | Pulmonary Hypoplasia | Diaphragmatic HerniaUnited Kingdom, Canada, United States, Belgium, Italy, Germany, France, Japan, Australia, Poland, Spain