Back to resultsFetoscopic Tracheal Balloon Occlusion in Unborns With Severe Congenital Diaphragmatic Hernia - EUROTRIAL I
Primary Purpose
Diaphragmatic Hernia
Status
Withdrawn
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Fetoscopic tracheal balloon occlusion
Sponsored by
About this trial
This is an interventional treatment trial for Diaphragmatic Hernia focused on measuring Congenital diaphragmatic hernia, tracheal occlusion, fetus, fetal surgery, fetoscopy
Eligibility 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
Sites / Locations
- German Center for Fetal Surgery & Minimally-Invasive Therapy-University of Bonn
- Neonatal Intensive Care Unit (ECMO center), University of Mannheim
Outcomes
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
Full Information
NCT ID
NCT00373763
First Posted
September 6, 2006
Last Updated
August 22, 2008
Sponsor
University Hospital, Bonn
Collaborators
Universitätsmedizin Mannheim
1. Study Identification
Unique Protocol Identification Number
NCT00373763
Brief Title
Fetoscopic Tracheal Balloon Occlusion in Unborns With Severe Congenital Diaphragmatic Hernia - EUROTRIAL I
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 Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Withdrawn
Why Stopped
No patients could be recruited and randomized due to other center offering backdoor for treatment.
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Bonn
Collaborators
Universitätsmedizin Mannheim
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diaphragmatic Hernia
Keywords
Congenital diaphragmatic hernia, tracheal occlusion, fetus, fetal surgery, fetoscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Fetoscopic tracheal balloon occlusion
Primary Outcome Measure Information:
Title
Survival to discharge from hospital
Secondary Outcome Measure Information:
Title
Maternal morbidity
Title
Fetal morbidity
Title
Premature preterm rupture of membranes
Title
Unintended preterm delivery
Title
Conventional ventilation strategies possible
Title
ECMO required
Title
Days in intensive care
Title
Days in hospital
Title
Oxygen dependency on discharge
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Kohl, MD
Organizational Affiliation
German Center for Fetal Surgery & Minimally-Invasive Therapy, University of Bonn, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Schaible, MD
Organizational Affiliation
Neonatal Intensive Care Unit (ECMO center), University of Mannheim, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
German Center for Fetal Surgery & Minimally-Invasive Therapy-University of Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Neonatal Intensive Care Unit (ECMO center), University of Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
16601345
Citation
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. doi: 10.1159/000091363.
Results Reference
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Fetoscopic Tracheal Balloon Occlusion in Unborns With Severe Congenital Diaphragmatic Hernia - EUROTRIAL I
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