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

This study has been withdrawn prior to enrollment.
(No patients could be recruited and randomized due to other center offering backdoor for treatment.)
Sponsor:
Collaborator:
Universitätsmedizin Mannheim
Information provided by:
University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT00373763
First received: September 6, 2006
Last updated: August 22, 2008
Last verified: August 2008

September 6, 2006
August 22, 2008
January 2007
January 2008   (final data collection date for primary outcome measure)
Survival to discharge from hospital
Same as current
Complete list of historical versions of study NCT00373763 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Fetoscopic Tracheal Balloon Occlusion in Unborns With Severe Congenital Diaphragmatic Hernia - EUROTRIAL I
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Diaphragmatic Hernia
Procedure: Fetoscopic tracheal balloon occlusion
Not Provided
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.
 
Withdrawn
98
Not Provided
January 2008   (final data collection date for primary outcome measure)

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
Female
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00373763
DH-EUROTRIAL I - 093/06, 093/06
Not Provided
Thomas Kohl MD, German Center for Fetal Surgery & Minimally-Invasive Therapy
University Hospital, Bonn
Universitätsmedizin Mannheim
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
University Hospital, Bonn
August 2008

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