Diaphragmatic Hernia
Conditions
Keywords
Congenital diaphragmatic hernia, tracheal occlusion, fetus, fetal surgery, fetoscopy, ECMO
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.
Interventions
Maternal local anesthesia, percutaneous ultrasound-guided fetal analgo-sedation and relaxation, percutaneous ultrasound-guided access into amniotic cavity with trocar, fetoscopic tracheal ballon occlusion, removal of fetoscope and trocar, maternal abdominal closure, skin-to-skin time 30 minutes
Sponsors
Universitätsmedizin Mannheim
University Hospital, Bonn
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Need for postnatal ECMO therapy | First two days of life |
Secondary
| Measure | Time frame |
|---|---|
| Maternal morbidity | Until maternal discharge |
| Fetal / Neonatal morbidity | Overall & at discharge from hospital |
| Premature preterm rupture of membranes | Following the interventions over the remainder of gestation |
| Survival to discharge from hospital | Days to discharge |
| Days in intensive care | Number of day until discharge from ICU |
| Days in hospital | Number of days until discharge from hospital |
| Oxygen dependency on discharge | Days until discharge |
| Unintended preterm delivery | Following the interventions before scheduled elective delivery |
Countries
Germany
Contacts
Primary ContactThomas Kohl, MD
Backup ContactThomas Schaible, MD
Outcome results
None listed