Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO) (FETO)

Fetal Endoscopic Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH) NCT3138863

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 Overview

• Status: Not yet recruiting
• Conditions: Congenital Diaphragmatic Hernia; Pulmonary Artery Hypertension; Pulmonary Hypoplasia
• Intervention / Treatment: Device: BALT GoldbBAL2 Detachable Balloon; Device: Catheter System

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rodrigo A Ruano, MD, Ph.D; Phone Number: 305.689.8001; Email: rodrigo.ruano@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
      • Contact: Rodrigo Ruano, MD, Ph.D; Phone Number: 305-689-8001; Email: rodrigo.ruano@miami.edu
      • Principal Investigator: Rodrigo Ruano, M.D.
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FETO Group; Participants undergoing fetal endoscopic tracheal occlusion (FETO) surgery by insertion of the BALT GoldbBAL2 Detachable Balloon with the BALT catheter system.	Device: BALT GoldbBAL2 Detachable Balloon; Latex balloon, with radio-opaque inclusion; Device: Catheter System; 100 cm tapered micro-catheter; Other Names: BALTACCIBDPE100

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of successfully completed FETO procedures	The number of successful placement and removal of balloon during FETO procedure	Up to 34 weeks gestation
Operative time	FETO placement and release operative times reported in minutes	Up to 34 weeks gestation
Frequency of unplanned balloon removal	The frequency of non-emergent and emergent completion of FETO release (unplanned balloon removal)	Up to 34 weeks gestation
Number of incidences of maternal complications	Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis	Up to 41 weeks gestation
Number of participants with maternal complications	Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis	Up to 41 weeks gestation
Gestational Age at Delivery	Gestation Age reported at time of delivery	Up to 41 weeks gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fetal Lung Growth as measured via Fetal Lung Volume	Fetal Lung Volume as measured via ultrasound	Up to 41 weeks gestation
Fetal Lung Growth as measured via LHR	Lung area to head circumference Ratio (LHR) as measured via ultrasound	Up to 41 weeks gestation
Fetal survival	Fetal survival reported in days	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	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	Up to 24 months post partum
Number of infants requiring ECMO Support	Number of infants reported that required Extracorporeal membrane oxygenation (ECMO) support	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	Up to 24 months post partum
Number of days of ventilator support	Number of reported days infants required ventilator support	Up to 24 months post partum
Number of days of maternal hospitalization	Number of reported days of maternal hospitalization	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	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	Up to 24 months post partum
Number of participants at each route of delivery	Number of participants that delivered vaginally and via caesarean section	Day 1 (post partum)
Number of days of Diaphragmatic Repair	Number of days of infant Diaphragmatic Repair	Up to 24 months post partum

Collaborators and Investigators

• Sponsor: Rodrigo Ruano
• Investigators: Principal Investigator: Rodrigo Ruano, M.D., Ph.D., University of Miami

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: May 1, 2017
• First Submitted That Met QC Criteria: May 1, 2017
• First Posted (Actual): May 3, 2017

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: congenital diaphragmatic hernia; pulmonary hypoplasia; fetal surgery; fetal lungs; tracheal occlusion
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Internal Hernia; Hypertension, Pulmonary; Hernia; Pulmonary Arterial Hypertension; Hernias, Diaphragmatic, Congenital; Hernia, Diaphragmatic
• Other Study ID Numbers: 20220033-1; 16-008720 (Other Identifier: Mayo Clinic)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes