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This study has been withdrawn prior to enrollment.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. )

First Received on September 6, 2006. Last Updated on August 22, 2008 History of Changes

Sponsor:	University Hospital, Bonn
Collaborator:	University Hospital Mannheim
Information provided by:	University Hospital, Bonn
ClinicalTrials.gov Identifier:	NCT00373763

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:

Genetics Home Reference related topics: congenital diaphragmatic hernia

MedlinePlus related topics: Hernia Hiatal Hernia

U.S. FDA Resources

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

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

University Hospital 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:

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.

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
Hernia, Hiatal
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on February 12, 2012