Clinical trial NCT00373438: Fetoscopic Tracheal Balloon Occlusion in Left Diaphragmatic Hernia
Official title: Randomized Clinical Trial in Order to Assess the Effect of Fetoscopic Tracheal Balloon Occlusion on the Postnatal Disease Course in Neonates With Left Congenital Diaphragmatic Hernia - FDH-ECMO/BALLOON-TRIAL
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diaphragmatic Hernia
Keywords: Congenital diaphragmatic hernia
tracheal occlusion
fetus
fetal surgery
fetoscopy
ECMO
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: PARALLEL
Primary purpose: TREATMENT

Brief summary: Left diaphragmatic hernia detected during fetal life carries a high risk for postnatal lung failure due to lung underdevelopment and pulmonary hypertension. In severe cases, extracorporeal membrane oxygenation (ECMO) is used as a life-saving intensive care means to enable survival of severely affected infants.

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 in a less severely affected subgroup of patients is whether by fetoscopic tracheal occlusion, the intensity of postnatal intensive care therapy might be reduced. Primary outcome measure is the need for postnatal ECMO therapy.


Eligibility criteria: Inclusion Criteria:

* Pregnant women from European countries carrying fetuses with left diaphragmatic hernia.
* Normal karyotype, no further severe anomalies on prenatal ultrasound study.
* Fetal liver herniation into the chest; gestational age-related lung volume between 20-25% of normal as determined by magnetic resonance imaging between 30+0 - 34+0 weeks+days of gestation.

Exclusion Criteria:

* Any maternal disease or condition that would result in an increased risk to her health from the experimental procedure.
* Abnormal fetal karyotype, further severe fetal anomalies on prenatal ultrasound.

Primary outcomes:
measure: Need for postnatal ECMO therapy
timeFrame: First two days of life
Secondary outcomes:
measure: Survival to discharge from hospital
timeFrame: Days to discharge
measure: Maternal morbidity
timeFrame: Until maternal discharge
measure: Fetal / Neonatal morbidity
timeFrame: Overall & at discharge from hospital
measure: Premature preterm rupture of membranes
timeFrame: Following the interventions over the remainder of gestation
measure: Unintended preterm delivery
timeFrame: Following the interventions before scheduled elective delivery
measure: Days in intensive care
timeFrame: Number of day until discharge from ICU
measure: Days in hospital
timeFrame: Number of days until discharge from hospital
measure: Oxygen dependency on discharge
timeFrame: Days until discharge
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: German Center for Fetal Surgery & Minimally Invasive Therapy
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.