| September 6, 2006 |
| January 5, 2009 |
| January 2009 |
| January 2014 (final data collection date for primary outcome measure) |
| Need for postnatal ECMO therapy [ Time Frame: First two days of life ] [ Designated as safety issue: Yes ] |
| Need for postnatal ECMO therapy |
| Complete list of historical versions of study NCT00373438 on ClinicalTrials.gov Archive Site |
- Survival to discharge from hospital [ Time Frame: Days to discharge ] [ Designated as safety issue: No ]
- Maternal morbidity [ Time Frame: Until maternal discharge ] [ Designated as safety issue: Yes ]
- Fetal / Neonatal morbidity [ Time Frame: Overall & at discharge from hospital ] [ Designated as safety issue: Yes ]
- Premature preterm rupture of membranes [ Time Frame: Following the interventions over the remainder of gestation ] [ Designated as safety issue: Yes ]
- Unintended preterm delivery [ Time Frame: Following the interventions before scheduled elective delivery ] [ Designated as safety issue: Yes ]
- Days in intensive care [ Time Frame: Number of day until discharge from ICU ] [ Designated as safety issue: Yes ]
- Days in hospital [ Time Frame: Number of days until discharge from hospital ] [ Designated as safety issue: Yes ]
- Oxygen dependency on discharge [ Time Frame: Days until discharge ] [ Designated as safety issue: Yes ]
|
- Survival to discharge from hospital
- Maternal morbidity
- Fetal morbidity
- Premature preterm rupture of membranes
- Unintended preterm delivery
- Days in intensive care
- Days in hospital
- Oxygen dependency on discharge
|
| |
| Fetoscopic Tracheal Balloon Occlusion in Left Diaphragmatic Hernia |
| 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 |
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. |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Diaphragmatic Hernia |
| Procedure: Fetoscopic tracheal balloon occlusion |
| Experimental: Fetoscopic tracheal occlusion |
| 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. |
| |
| Recruiting |
| 98 |
| July 2014 |
| January 2014 (final data collection date for primary outcome measure) |
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.
|
| Female |
| 18 Years to 50 Years |
| Yes |
|
|
| Germany |
| |
| NCT00373438 |
| Thomas Kohl MD, German Center for Fetal Surgery & Minimally-Invasive Therapy |
| FDH-ECMO/BALLOON-TRIAL-135/06, 135/06 |
| University Hospital, Bonn |
| University Hospital Mannheim |
| 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 |
|
|
| University Hospital, Bonn |
| January 2009 |