Clinical trial NCT03138863: Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO)
Official title: Fetal Endoscopic Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH) NCT3138863
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Congenital Diaphragmatic Hernia
Pulmonary Hypoplasia
Pulmonary Artery Hypertension
Keywords: fetal lungs
fetal surgery
congenital diaphragmatic hernia
tracheal occlusion
pulmonary hypoplasia
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of successfully completed FETO procedures
timeFrame: Up to 34 weeks gestation
measure: Operative time
timeFrame: Up to 34 weeks gestation
measure: Frequency of unplanned balloon removal
timeFrame: Up to 34 weeks gestation
measure: Number of incidences of maternal complications
timeFrame: Up to 41 weeks gestation
measure: Number of participants with maternal complications
timeFrame: Up to 41 weeks gestation
measure: Gestational Age at Delivery
timeFrame: Up to 41 weeks gestation
Secondary outcomes:
measure: Fetal Lung Growth as measured via Fetal Lung Volume
timeFrame: Up to 41 weeks gestation
measure: Fetal Lung Growth as measured via LHR
timeFrame: Up to 41 weeks gestation
measure: Fetal survival
timeFrame: Up to 24 months post partum
measure: Number of newborns reported at each oxygen dependency grading
timeFrame: Up to 24 months post partum
measure: Number of occurrence of severe pulmonary hypertension
timeFrame: Up to 24 months post partum
measure: Number of infants requiring ECMO Support
timeFrame: Up to 24 months post partum
measure: Number of days in neonatal intensive care unit
timeFrame: Up to 24 months post partum
measure: Number of days of ventilator support
timeFrame: Up to 24 months post partum
measure: Number of days of maternal hospitalization
timeFrame: Up to 24 months post partum
measure: Number of infants reporting presence of complications
timeFrame: Up to 24 months post partum
measure: Number of infants requiring the use of patch or muscle flap
timeFrame: Up to 24 months post partum
measure: Number of participants at each route of delivery
timeFrame: Day 1 (post partum)
measure: Number of days of Diaphragmatic Repair
timeFrame: Up to 24 months post partum
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: University of Miami
name: Rodrigo Ruano, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: