Fetoscopic balloon (FETO) for severe left and right congenital diaphragmatic hernia — long-term outcomes

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

This trial will try placing and later removing a tiny balloon in the fetal windpipe around 27–29 weeks to help babies with severe congenital diaphragmatic hernia and liver herniation survive the newborn period.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: The University of Texas Health Science Center, Houston (Academic / other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT06739356 on ClinicalTrials.gov

What this trial studies

This interventional protocol compares fetal treatment with fetoscopic endoluminal tracheal occlusion (FETO) to expectant management for severe isolated congenital diaphragmatic hernia (CDH) with intrathoracic liver herniation. In the FETO arm a small balloon is placed in the fetal trachea at about 27+0 to 29+6 weeks to encourage lung growth, then removed before delivery, and patients are closely monitored for cervical changes and maternal complications. Eligible fetuses are singleton with normal genetic testing and meet O/E LHR thresholds (left CDH <30% or right CDH <45%). The main outcome is neonatal survival to NICU discharge, with longer-term outcomes collected through follow-up.

Who should consider this trial

Good fit: Pregnant people carrying a singleton fetus with isolated left CDH and O/E LHR under 30% or isolated right CDH with O/E LHR under 45% plus intrathoracic liver herniation, normal genetic testing, adequate cervical length, and who can consent and attend the Houston center are appropriate candidates.

Not a fit: Those with multiple gestation, major chromosomal/genetic abnormalities, active preterm labor or a short cervix (<20 mm), latex allergy, or inability to travel to the treating center are unlikely to benefit from this procedure.

Why it matters

Potential benefit: If successful, FETO could increase the chance that babies with severe CDH and liver herniation survive to leave the NICU.

How similar studies have performed: Prior FETO research has shown improved lung growth and higher survival in selected severe left CDH cases, but results are variable and the procedure carries significant risks such as preterm birth.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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:

  1. Inability to reside within 30 minutes of University of Texas Health Science Center at Houston Fetal Center
  2. 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
* Participation in another intervention study that influences maternal and fetal morbidity and mortality. or participation in this trial in a previous pregnancy

Where this trial is running

Houston, Texas

• The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Anthony Johnson, DO — The University of Texas Health Science Center, Houston
• Study coordinator: Anthony Johnson, DO

Conditions Congenital Diaphragmatic Hernia; Fetoscopic Endoluminal Tracheal Occlusion