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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: Anthony.Johnson@uth.tmc.edu
• Phone: (713) 500-5859

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• FETO with a Goldballoon device for fetuses with diaphragmatic hernia

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• Fetal tracheal occlusion (FETO) for severe congenital diaphragmatic hernia

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• Long-term outcomes after FETO for severe left or right congenital diaphragmatic hernia

  This trial will test whether performing FETO in fetuses with isolated severe left or right CDH helps more babies survive to hospital discharge and have fewer long-term problems than standard care.

  Recruiting Johns Hopkins University · Baltimore, Maryland · NCT07166172

• Fetal treatment for congenital diaphragmatic hernia

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• Arginine and ADMA levels during recovery from neonatal abdominal surgery

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.