The purpose of this research is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Latex balloon, with radio-opaque inclusion
100 cm tapered micro-catheter
University of Miami
Miami, Florida, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
TERMINATEDNumber of successfully completed FETO procedures
The number of successful placement and removal of balloon during FETO procedure
Time frame: Up to 34 weeks gestation
Operative time
FETO placement and release operative times reported in minutes
Time frame: Up to 34 weeks gestation
Frequency of unplanned balloon removal
The frequency of non-emergent and emergent completion of FETO release (unplanned balloon removal)
Time frame: Up to 34 weeks gestation
Number of incidences of maternal complications
Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis
Time frame: Up to 41 weeks gestation
Number of participants with maternal complications
Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis
Time frame: Up to 41 weeks gestation
Gestational Age at Delivery
Gestation Age reported at time of delivery
Time frame: Up to 41 weeks gestation
Fetal Lung Growth as measured via Fetal Lung Volume
Fetal Lung Volume as measured via ultrasound
Time frame: Up to 41 weeks gestation
Fetal Lung Growth as measured via LHR
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Lung area to head circumference Ratio (LHR) as measured via ultrasound
Time frame: Up to 41 weeks gestation
Fetal survival
Fetal survival reported in days
Time frame: Up to 24 months post partum
Number of newborns reported at each oxygen dependency grading
Oxygen dependency graded as none, mild, moderate, severe as assessed by treating physician
Time frame: Up to 24 months post partum
Number of occurrence of severe pulmonary hypertension
Number of occurrence of severe pulmonary hypertension in infants as measured via echocardiogram
Time frame: Up to 24 months post partum
Number of infants requiring ECMO Support
Number of infants reported that required Extracorporeal membrane oxygenation (ECMO) support
Time frame: Up to 24 months post partum
Number of days in neonatal intensive care unit
Number of days infant was in the neonatal intensive care unit
Time frame: Up to 24 months post partum
Number of days of ventilator support
Number of reported days infants required ventilator support
Time frame: Up to 24 months post partum
Number of days of maternal hospitalization
Number of reported days of maternal hospitalization
Time frame: Up to 24 months post partum
Number of infants reporting presence of complications
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
Time frame: Up to 24 months post partum
Number of infants requiring the use of patch or muscle flap
Number of infants reported to require the use of patch or muscle flap
Time frame: Up to 24 months post partum
Number of participants at each route of delivery
Number of participants that delivered vaginally and via caesarean section
Time frame: Day 1 (post partum)
Number of days of Diaphragmatic Repair
Number of days of infant Diaphragmatic Repair
Time frame: Up to 24 months post partum