The purpose of this research is to gather information on the safety and effectiveness of a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) at Mayo Clinic. The intent of the FETO procedure is to improve development of the lungs in fetuses diagnosed with severe congenital diaphragmatic hernia (CDH).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Inflated with fluid in the fetal trachea and provide with the occlusion necessary to promote lung growth.
Used to deliver the detachable balloon
Used to percutaneously enter though the maternal abdominal wall, uterus and into the amniotic cavity, fetal mouth, pharynx, larynx, into the trachea where the delivery catheter will be used to deliver the detachable balloon that will provide with the tracheal occlusion.
Mayo Clinic Minnesota
Rochester, Minnesota, United States
RECRUITINGTechnical success of the balloon placement procedure
The number of successful balloon placement procedures defined as balloon was correctly inflated and placed/secured in the trachea.
Time frame: Up to 29 weeks gestation
Technical success of balloon retrieval procedure
The number of successful balloon retrieval procedure defined as antenatal removal of the balloon.
Time frame: Up to 34 weeks gestation
Operative times
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
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 24 months post partum
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 24 months post partum
Fetal Survival
Survival at 30 days, discharge from the hospital and at 6 months if still hospitalized
Time frame: Up to 6 months post partum
Fetal Oxygen Dependency
Oxygen dependency graded as none, mild, moderate, severe as assessed by treating physician
Time frame: Up to 24 months post partum
Occurrence of severe pulmonary hypertension
Number of occurrence of severe pulmonary hypertension in infants based on echocardiogram
Time frame: Up to 24 months post partum
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 NICU
Number of days infant was in 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 periventricular leukomalacia at < 2 months postnatally
Number of infants reported presence of periventricular leukomalacia at \< 2 months postnatally
Time frame: Up to 2 months post partum
Number of infant complications
Number of infants reporting the presence of: neonatal sepsis, intraventricular hemorrhage (grade 3 or higher), retinopathy of prematurity (grade 3 or higher) or gastro-esophageal reflux
Time frame: Up to 24 months post partum
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
Maternal hospitalization
Number of reported days of maternal hospitalization
Time frame: Up to 24 months post partum
Route of delivery
Number of participants that delivered vaginally and via caesarean section
Time frame: Day 1 (post partum)