Clinical trial NCT00373763: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Diaphragmatic Hernia
Keywords: Congenital diaphragmatic hernia
tracheal occlusion
fetus
fetal surgery
fetoscopy
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
Collaborators: name: Universitätsmedizin Mannheim
First posted: 2006-09-08
Enrollment: 98
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Survival to discharge from hospital
Secondary outcomes:
measure: Maternal morbidity
measure: Fetal morbidity
measure: Premature preterm rupture of membranes
measure: Unintended preterm delivery
measure: Conventional ventilation strategies possible
measure: ECMO required
measure: Days in intensive care
measure: Days in hospital
measure: Oxygen dependency on discharge
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: German Center for Fetal Surgery & Minimally-Invasive Therapy-University of Bonn
city: Mannheim
country: Germany
facility: Neonatal Intensive Care Unit (ECMO center), University of Mannheim
Study officials:
affiliation: German Center for Fetal Surgery & Minimally-Invasive Therapy, University of Bonn, Germany
name: Thomas Kohl, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neonatal Intensive Care Unit (ECMO center), University of Mannheim, Germany
name: Thomas Schaible, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.