Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO)

Not Applicable

Active, not recruiting

• Conditions: Congenital Diaphragmatic Hernia; Pulmonary Artery Hypertension; Pulmonary Hypoplasia
• Interventions: Device: BALT GoldbBAL2 Detachable Balloon; Device: Catheter System

• Registration Number: NCT03138863
• Lead Sponsor: Rodrigo Ruano

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-01
• Study First Submitted QC: 2017-05-01
• Study First Posted: 2017-05-03
• Study Start: 2024-05-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Primary Completion: 2026-12-01
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FETO Group	Catheter System	Participants undergoing fetal endoscopic tracheal occlusion (FETO) surgery by insertion of the BALT GoldbBAL2 Detachable Balloon with the BALT catheter system.
FETO Group	BALT GoldbBAL2 Detachable Balloon	Participants undergoing fetal endoscopic tracheal occlusion (FETO) surgery by insertion of the BALT GoldbBAL2 Detachable Balloon with the BALT catheter system.

Primary Outcome Measures

Name	Time	Method
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
Operative time	Up to 34 weeks gestation	FETO placement and release operative times reported in minutes
Number of successfully completed FETO procedures	Up to 34 weeks gestation	The number of successful placement and removal of balloon during FETO procedure
Gestational Age at Delivery	Up to 41 weeks gestation	Gestation Age reported at time of delivery

Secondary Outcome Measures

Name	Time	Method
Fetal Lung Growth as measured via Fetal Lung Volume	Up to 41 weeks gestation	Fetal Lung Volume as measured via ultrasound
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
Fetal Lung Growth as measured via LHR	Up to 41 weeks gestation	Lung area to head circumference Ratio (LHR) as measured via ultrasound
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 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 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
Fetal survival	Up to 24 months post partum	Fetal survival reported in days
Number of days of ventilator support	Up to 24 months post partum	Number of reported days infants required ventilator support
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
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 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

Trial Locations

Locations (2)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University of Miami; 🇺🇸 Miami, Florida, United States