Congenital Diaphragmatic Hernia, Pulmonary Artery Hypertension, Pulmonary Hypoplasia
Conditions
Keywords
fetal lungs, fetal surgery, congenital diaphragmatic hernia, tracheal occlusion, pulmonary hypoplasia
Brief summary
The purpose of this research is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO).
Interventions
DEVICEBALT GoldbBAL2 Detachable Balloon
Latex balloon, with radio-opaque inclusion
DEVICECatheter System
100 cm tapered micro-catheter
Sponsors
Rodrigo Ruano
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Singleton pregnancy * Normal fetal karyotype with confirmation by culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \> 26 weeks. * Isolated Left CDH with liver up * Gestation age at enrollment prior to 29 wks plus 6 days severe pulmonary hypoplasia with ultrasound (US) O/E lung area to head circumference ratio (LHR) \< 25% (measured at 180 to 296 weeks) at the time of surgery; O/E LHR 25% to \<30% (measured at 300 to 316 weeks) at time of surgery. * Gestational age at FETO procedure with O/E LHR \<25% at 27 weeks 0 days to 29 weeks 6 days; with O/E LHR 25% to \<30% at 30 weeks 0 days to 31 weeks 6 days as determined by clinical information (LMP) and evaluation of first ultrasound * Patient meets psychosocial criteria
Exclusion criteria
* Multi-fetal pregnancy * History of natural rubber latex allergy * Preterm labor, cervix shortened (\<15 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa * Psychosocial ineligibility, precluding consent: * Inability to reside within 30 minute drive of our hospital, and inability to comply with the travel for the follow-up requirements of the trial * Patient does not have a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at our institution. * Right sided CDH or bilateral CDH, isolated left sided with O/E LHR ≥30% (measured at 180 to 295 weeks) as determined by ultrasound * Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram at the fetal treatment center. No cases will be removed post hoc if abnormalities are discovered in the course of postoperative monitoring * Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy * History of incompetent cervix with or without cerclage * Placental abnormalities (previa, abruption, accrete) known at time of enrollment * Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy * Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality * Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of successfully completed FETO procedures | Up to 34 weeks gestation | The number of successful placement and removal of balloon during FETO procedure |
| Operative time | Up to 34 weeks gestation | FETO placement and release operative times reported in minutes |
| Frequency of unplanned balloon removal | Up to 34 weeks gestation | The frequency of non-emergent and emergent completion of FETO release (unplanned balloon removal) |
| Number of incidences of maternal complications | Up to 41 weeks gestation | Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis |
| Number of participants with maternal complications | Up to 41 weeks gestation | Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis |
| Gestational Age at Delivery | Up to 41 weeks gestation | Gestation Age reported at time of delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fetal Lung Growth as measured via Fetal Lung Volume | Up to 41 weeks gestation | Fetal Lung Volume as measured via ultrasound |
| Fetal Lung Growth as measured via LHR | Up to 41 weeks gestation | Lung area to head circumference Ratio (LHR) as measured via ultrasound |
| Fetal survival | Up to 24 months post partum | Fetal survival reported in days |
| Number of newborns reported at each oxygen dependency grading | Up to 24 months post partum | Oxygen dependency graded as none, mild, moderate, severe as assessed by treating physician |
| Number of occurrence of severe pulmonary hypertension | Up to 24 months post partum | Number of occurrence of severe pulmonary hypertension in infants as measured via echocardiogram |
| Number of infants requiring ECMO Support | Up to 24 months post partum | Number of infants reported that required Extracorporeal membrane oxygenation (ECMO) support |
| Number of days in neonatal intensive care unit | Up to 24 months post partum | Number of days infant was in the neonatal intensive care unit |
| Number of days of ventilator support | Up to 24 months post partum | Number of reported days infants required ventilator support |
| Number of days of maternal hospitalization | Up to 24 months post partum | Number of reported days of maternal hospitalization |
| Number of infants reporting presence of complications | Up to 24 months post partum | Number of infants reporting the presence of: periventricular leucomalacia at \< 2 months postnatally, neonatal sepsis, intraventricular hemorrhage (grade 0-III), retinopathy of prematurity (grade III or higher), gastro-esophageal reflux, tracheomegaly and tracheomalacia |
| Number of infants requiring the use of patch or muscle flap | Up to 24 months post partum | Number of infants reported to require the use of patch or muscle flap |
| Number of participants at each route of delivery | Day 1 (post partum) | Number of participants that delivered vaginally and via caesarean section |
| Number of days of Diaphragmatic Repair | Up to 24 months post partum | Number of days of infant Diaphragmatic Repair |
Countries
United States
Contacts
CONTACTRodrigo A Ruano, MD, Ph.D
PRINCIPAL_INVESTIGATORRodrigo Ruano, M.D., Ph.D.
University of Miami
Outcome results
None listed