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Fetoscopic Tracheal Balloon Occlusion in Unborns With Severe Congenital Diaphragmatic Hernia - EUROTRIAL I

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00373763
Recruitment Status : Withdrawn (No patients could be recruited and randomized due to other center offering backdoor for treatment.)
First Posted : September 8, 2006
Last Update Posted : August 25, 2008
Universitätsmedizin Mannheim
Information provided by:
University Hospital, Bonn

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diaphragmatic Hernia Procedure: Fetoscopic tracheal balloon occlusion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2007
Actual Primary Completion Date : January 2008

Primary Outcome Measures :
  1. Survival to discharge from hospital

Secondary Outcome Measures :
  1. Maternal morbidity
  2. Fetal morbidity
  3. Premature preterm rupture of membranes
  4. Unintended preterm delivery
  5. Conventional ventilation strategies possible
  6. ECMO required
  7. Days in intensive care
  8. Days in hospital
  9. Oxygen dependency on discharge

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00373763

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German Center for Fetal Surgery & Minimally-Invasive Therapy-University of Bonn
Bonn, Germany, 53105
Neonatal Intensive Care Unit (ECMO center), University of Mannheim
Mannheim, Germany, 68167
Sponsors and Collaborators
University Hospital, Bonn
Universitätsmedizin Mannheim
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Principal Investigator: Thomas Kohl, MD German Center for Fetal Surgery & Minimally-Invasive Therapy, University of Bonn, Germany
Principal Investigator: Thomas Schaible, MD Neonatal Intensive Care Unit (ECMO center), University of Mannheim, Germany
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Responsible Party: Thomas Kohl MD, German Center for Fetal Surgery & Minimally-Invasive Therapy Identifier: NCT00373763    
Other Study ID Numbers: DH-EUROTRIAL I - 093/06
First Posted: September 8, 2006    Key Record Dates
Last Update Posted: August 25, 2008
Last Verified: August 2008
Keywords provided by University Hospital, Bonn:
Congenital diaphragmatic hernia
tracheal occlusion
fetal surgery
Additional relevant MeSH terms:
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Hernias, Diaphragmatic, Congenital
Hernia, Diaphragmatic
Pathological Conditions, Anatomical
Congenital Abnormalities