Diaphragmatic Hernia
Conditions
Keywords
Congenital diaphragmatic hernia, tracheal occlusion, fetus, fetal surgery, fetoscopy
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.
Interventions
Sponsors
Universitätsmedizin Mannheim
University Hospital, Bonn
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival to discharge from hospital | — |
Secondary
| Measure | Time frame |
|---|---|
| Fetal morbidity | — |
| Premature preterm rupture of membranes | — |
| Unintended preterm delivery | — |
| Conventional ventilation strategies possible | — |
| Maternal morbidity | — |
| Days in intensive care | — |
| Days in hospital | — |
| Oxygen dependency on discharge | — |
| ECMO required | — |
Countries
Germany
Outcome results
None listed