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

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ClinicalTrials.gov 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Recruitment Status : Withdrawn (No patients could be recruited and randomized due to other center offering backdoor for treatment.)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
Sponsor:
Collaborator:
Universitätsmedizin Mannheim
Information provided by:
University Hospital, Bonn

Tracking Information
First Submitted Date  ICMJE September 6, 2006
First Posted Date  ICMJE September 8, 2006
Last Update Posted Date August 25, 2008
Study Start Date  ICMJE January 2007
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2006)
Survival to discharge from hospital
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00373763 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2006)
  • Maternal morbidity
  • Fetal morbidity
  • Premature preterm rupture of membranes
  • Unintended preterm delivery
  • Conventional ventilation strategies possible
  • ECMO required
  • Days in intensive care
  • Days in hospital
  • Oxygen dependency on discharge
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fetoscopic Tracheal Balloon Occlusion in Unborns With Severe Congenital Diaphragmatic Hernia - EUROTRIAL I
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diaphragmatic Hernia
Intervention  ICMJE Procedure: Fetoscopic tracheal balloon occlusion
Study Arms  ICMJE Not Provided
Publications * Kohl T, Gembruch U, Filsinger B, Hering R, Bruhn J, Tchatcheva K, Aryee S, Franz A, Heep A, Muller A, Bartmann P, Loff S, Hosie S, Neff W, Schaible T; German Center for Fetal Surgery Diaphragmatic Hernia Task Group. Encouraging early clinical experience with deliberately delayed temporary fetoscopic tracheal occlusion for the prenatal treatment of life-threatening right and left congenital diaphragmatic hernias. Fetal Diagn Ther. 2006;21(3):314-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Estimated Enrollment  ICMJE
 (submitted: September 11, 2006)
98
Original Enrollment  ICMJE
 (submitted: September 6, 2006)
78
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00373763
Other Study ID Numbers  ICMJE DH-EUROTRIAL I - 093/06
093/06
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas Kohl MD, German Center for Fetal Surgery & Minimally-Invasive Therapy
Study Sponsor  ICMJE University Hospital, Bonn
Collaborators  ICMJE Universitätsmedizin Mannheim
Investigators  ICMJE
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
PRS Account University Hospital, Bonn
Verification Date August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP