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This study has been withdrawn prior to enrollment.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
  Purpose

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 Intervention
Diaphragmatic Hernia
Procedure: Fetoscopic tracheal balloon occlusion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:
  • Survival to discharge from hospital

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 98
Study Start Date: January 2007
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373763

Locations
Germany
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
Investigators
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
  More Information

Publications:
Responsible Party: Thomas Kohl MD, German Center for Fetal Surgery & Minimally-Invasive Therapy
ClinicalTrials.gov Identifier: NCT00373763     History of Changes
Other Study ID Numbers: DH-EUROTRIAL I - 093/06, 093/06
Study First Received: September 6, 2006
Last Updated: August 22, 2008
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital, Bonn:
Congenital diaphragmatic hernia
tracheal occlusion
fetus
fetal surgery
fetoscopy

Additional relevant MeSH terms:
Hernia
Hernia, Diaphragmatic
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 29, 2014