Congenital Diaphragmatic Hernia
Conditions
Keywords
congenital diaphragmatic hernia, fetoscopy, fetal endoscopic tracheal occlusion, pulmonary hypoplasia, fetal surgery, fetal lung
Brief summary
Congenital diaphragmatic hernia (CDH) is associated high mortality and morbidity, mainly in those cases with severe forms where there are extremely reduced lung volumes, liver herniation and decreased abnormal pulmonary vascularization. Fetal endoscopic tracheal occlusion performed between 26 and 30 weeks (standard FETO) has been shown to increase fetal pulmonary size and vascularity, and to improve infant survival in isolated severe CDH. Fetal pulmonary response followed FETO can be used to predict outcome and is dependent on the size of the fetal lung prior to the procedure. We hypothesize that performing an earlier FETO, between 22-24 weeks, fetuses with severe form of CDH will have a better fetal pulmonary response and higher chance of surviving.
Detailed description
We pretend to investigate if early FETO will improve the survival rate and the fetal pulmonary response, by conducting a randomized controlled trial comparing the results with those fetuses that undergo to standard FETO (between 26-28 weeks).
Interventions
OTHERFetal endoscopic tracheal occlusion
FETO will be performed by placing a detachable balloon inside fetal trachea
Sponsors
University of Sao Paulo
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Weeks to 28 Weeks
Healthy volunteers
No
Inclusion criteria
* Fetuses with isolated congenital diaphragmatic hernia (normal fetal karyotype and absence of any associated structural anomaly); * Gestational age established by last menstruation and/or first trimester ultrasonography; * Prenatal diagnosis of congenital diaphragmatic hernia before 24 weeks of gestation * Severe congenital diaphragmatic hernia (at 24 weeks, lung-to-head ratio \<1.0 and at least 1/3 of the liver herniated into the fetal thorax) * written informed consent (by the patient)
Exclusion criteria
* Preterm premature rupture of the membranes before randomization * Preterm labor before randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infant survival rate | 6 months of life | Percentage of survivors at 6 months of life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postnatal severe pulmonary arterial hypertension (PAH) | 30 days of life | Severe PAH will be considered when the neonate presents with profound cyanosis associated with echocardiographic continuous right-to-left shunting through a persistent 'ductus arteriosus' and a persistent difference in pre- to postductal saturation gradient \>20%, despite the use of intake Nitric Oxide (iNO). |
| Respiratory morbidity | 6 months of life | Need for ventilatory support and/or oxygen dependency. |
Other
| Measure | Time frame | Description |
|---|---|---|
| obstetrical complications (morbidity) | pregnancy | 1. Preterm premature rupture of the membranes (\<37 weeks) 2. Extremely preterm premature rupture of the membranes (\<32 weeks) 3. Preterm delivery (birth \<37 weeks of gestation) 4. Extremely preterm delivery (birth \<32 weeks) 5. Placental abruption 6. Chorioamnionitis and maternal infection |
Countries
Brazil
Contacts
Primary ContactRodrigo Ruano, MD PhD
Backup ContactEugenia MA Salustiano, RN
Outcome results
None listed