North American Fetal Therapy Network for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia

NCT06739356 | Recruiting DMC FDA Device

• 1 other identifier: HSC-MS-24-0984
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate successful placement and removal of Fetoscopic Endoluminal Tracheal Occlusion (FETO) device in cases of intrathoracic liver herniation with isolated left congenital diaphragmatic hernia (LCDH) with Observed/Expected (O/E) Lung to Head Circumference Ratio (LHR) \< 30% or isolated right congenital diaphragmatic hernia (RCDH) with O/E LHR \< 45%,to compare survival to discharge from the neonatal intensive care units (NICU), between fetuses with intrathoracic liver herniation and isolated LCDH with O/E LHR \< 30% that receive FETO procedure performed at 27 weeks 0 days to 29weeks 6 days of gestation to those with intrathoracic liver herniation, isolated LCDH and o/e LRH \< 30% that undergo expectant management, to compare the neonatal survival rate to discharge from the neonatal intensive care units (NICU), between fetuses with intrathoracic liver herniation, isolated RCHD with o/e LHR \< 45% that undergo FETO procedure performed at 27 weeks 0 days to 29 weeks 6 days gestation to those with intrathoracic liver herniation, isolated RCHD and o/e LHR \< 45% that elect to proceed with expectant management, to evaluate the frequency of maternal and fetal complications associated with FETO procedure, to evaluate whether the FETO procedure is associated with reduced long-term mortality and morbidities in isolated LCDH survivors with o/e LHR \<30% when compared to isolated LCDH with o/e LRH \<30% that undergo expectant management where all fetuses were found to have intrathoracic liver herniation and to evaluate whether the FETO procedure is associated with reduced long-term mortality and morbidities in isolated RCDH survivors with o/e LHR ≤ 45% when compared to isolated RCHD with LHR \< 45% that undergo expectant management where all fetuses were found to have intrathoracic liver herniation

Conditions

Congenital Diaphragmatic Hernia

Keywords

Fetoscopic Endoluminal Tracheal Occlusion

Outcome Measures

Primary Outcomes (4)

• Number of neonates that survived

  from delivery to hospital discharge (up to 12 months)

• Number of Successful placement of FETO device

  10-60 minutes after surgery begins

• Number of Successful removal of FETO device

  immediately after the procedure (about 1 hour after start of surgery)

• FETO procedure complications

  Complications include, Failure FETO insertion procedure, FETO device dislodgement potentially requiring a second FETO insertion, Fetal intraoperative injury, Procedural hemorrhage, Bleeding from insertion site or Abruptions, Post-procedural hemorrhage PPROM, Preterm delivery, Chorioamnion separation,Chorioamnionitis, Polyhydramnios, Oligohydramnios,Emergent removal due to obstetrical complication, Failed percutaneous or fetoscopic removal requiring cesarean section or exit procedure for removal, Neonatal death due to asphyxia if delivery before FETO removal and Non-reassuring fetal heart rate monitoring

  end of study (24 months)

Secondary Outcomes (48)

• Number of infants that survived

  6 months

• Number of infants that survived

  12 months

• Number of infants that survived

  18 months

• Number of infants that survived

  24 months

• Number of infants that show presence of pulmonary hypertension

  6 months

Study Arms (2)

Fetal Treatment arm (FETO Group)

EXPERIMENTAL

Device: Fetal Treatment arm (FETO Group)

Expectant Management Arm (Control Group)

NO INTERVENTION

Interventions

Fetal Treatment arm (FETO Group) DEVICE

Participants will undergo FETO surgery at at 27 weeks 0 days - 29 weeks 6 days gestation.Balloon insertion into the fetal trachea will be performed. This will be followed by weekly \\ ultrasound monitoring and MRI at 3 weeks following FETO insertion and removal of the balloon which will be performed at at 34 weeks 0 days to 34 weeks 6 days. Planned delivery will occur after 37 weeks. The follow-up phase will be conducted from birth to 24 months of age

Fetal Treatment arm (FETO Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women who are able to consent
• Singleton pregnancy
• Normal Karyotype, chromosomal microanalysis (CMA) with non-pathologic variants, Whole exome sequencing (WES) or whole genome sequencing (WGS) . Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \> 26 weeks
• Gestational age at enrollment is prior to 296 wks.
• Intrathoracic liver herniation
• Isolated left CDH with o/e LHR \< 30% at enrollment (180 to 295 wks.). or
• Isolated RCDH with o/e LHR \< 45% at enrollment (180 to 295 wks.)
• Cervical length by transvaginal ultrasound \> 20 mm within 24 hours prior to FETO procedure
• Patient meets psychosocial criteria
• Informed consent understood

You may not qualify if:

• History of natural rubber latex allergy
• Preterm labor, cervix shortened (\<20 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 minutes of University of Texas Health Science Center at Houston Fetal Center
• The 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 UTHealth Houston Fetal Center
• Bilateral CDH, isolated left sided CDH with O/E LHR ≥ 30% (measured at 180 to 295 weeks), isolated right sided CDH with O/E LHR \> 45% (measured at 180 to 295 weeks), as determined by ultrasound
• No liver herniation into thoracic cavity
• Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram at the fetal treatment center. Exclude chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (i.e., CDH and congenital heart disease) or presence of an underlying genetic syndrome (i.e., Fryns).
• Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
• History of incompetent cervix with or without cerclage
• Placental abnormalities (previa, abruption, accreta) 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 anomalies such as large or multiple fibroids or Mullerian duct abnormality
• There is no safe or technically feasible fetoscopic approach to balloon placement

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Hernias, Diaphragmatic, Congenital

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Anthony Johnson, DO

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony Johnson, DO

CONTACT

(713) 500-5859; Anthony.Johnson@uth.tmc.edu

Elisa Garcia

CONTACT

(713) 500-7434; Elisa.I.Garcia@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 18, 2024
• Study Start: March 4, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2031
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)