Fetal tracheal occlusion (FETO) for severe congenital diaphragmatic hernia

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

Pregnant adults carrying a singleton fetus with intrathoracic liver herniation and severe lung hypoplasia (left CDH o/e LHR <30% or right CDH o/e LHR <45%) are enrolled at about 18 to 29 weeks' gestation. Enrolled participants receive either FETO using an FDA IDE–approved device or standard prenatal management matched for defect side and fetal lung volume estimates. The primary outcome is neonatal survival to hospital discharge, with secondary outcomes including long-term morbidity measures. Eligibility requires normal fetal karyotype, adequate cervical length, and meeting psychosocial and consent criteria, and procedures are performed at Cincinnati Children's Hospital Medical Center.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Pregnant women 18 years and older, who are able to consent
* Singleton pregnancy
* Gestational age at enrollment is prior to 296 weeks
* Intrathoracic liver herniation
* Isolated Left CDH with o/e LHR \< 30% at enrollment (180 to 295 weeks) or
* Isolated Right CDH with o/e LHR \< 45% at enrollment (180 to 295 weeks)
* Normal fetal karyotype with confirmation by culture results, CMA with non-pathological variants, WES or WGS. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \> 26 weeks
* Cervical length by transvaginal ultrasound \> 20 mm within 24 hours prior to FETO procedure
* Patient meets psychosocial criteria
* Informed consent understood

Exclusion Criteria

* Patient \< 18 years of age
* Multi-fetal pregnancy
* History of natural rubber latex allergy
* Preterm labor, cervix shortened (\< 20 mm at enrollment or within 24 hours prior to FETO balloon insertion) or uterine anomaly strongly predisposing to preterm labor, or placenta previa.
* Psychosocial ineligibility, precluding consent:

  * Inability to reside within 30 minutes of Cincinnati Children's Hospital Medical Center and inability to comply with the travel for the follow-up requirements of the trial.
  * 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 Cincinnati Children's Hospital Medical Center.
* Bilateral CDH, isolated LCDH with o/e LHR ≥ 30%, isolated RCDH with o/e LHR \> 45%, as determined by ultrasound.
* No liver herniation into thoracic cavity
* Additional fetal anomaly and chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (i.e., congenital heart disease) or presence of an underlying genetic syndrome (i.e., Fryns) by ultrasound, MRI, or echocardiogram at the fetal treatment center.
* 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 positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV status is unknown, the patient must be tested and found to have negative results before enrollment.
* Positive Hepatitis B surface antigen or presence of Hepatitis C in maternal blood uterine anomaly such as Mullerian duct abnormality, large or multiple fibroids that prohibit safe fetoscopic procedure
* 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

• Cincinnati Children's Hospital Medical Center (CCHMC)
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Study coordinator: Foong-Yen Lim, MD
• Email: Foong-Yen.Lim@cchmc.org
• Phone: (513) 636-6259

Similar studies

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

• Fetal treatment for congenital diaphragmatic hernia

  This study is testing a new way to treat congenital diaphragmatic hernia in unborn babies by placing a balloon in their airway to help their lungs grow before they are born.

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• Using Sildenafil to Treat Neonates with Congenital Diaphragmatic Hernia

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• Fetoscopic tracheal balloon occlusion for severe left congenital diaphragmatic hernia

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• Fetal tracheal occlusion for severe congenital diaphragmatic hernia

  This study is testing if a procedure called fetal tracheal occlusion can help improve lung development in unborn babies with severe congenital diaphragmatic hernia.

  Recruiting Children's Hospital Medical Center, Cincinnati · Cincinnati, Ohio · NCT02986087

• Levosimendan to see if it helps the heart after PEA in CTEPH

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• Melatonin plus inhaled nitric oxide for pulmonary hypertension in full-term newborns

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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.