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Recruiting NCT07187206

Safety and Efficacy of FETO in CDH Phase III

Phase III Interventional Congenital Diaphragmatic Hernia Pulmonary Hypoplasia Pulmonary Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FETO, Fetal Endoluminal Tracheal Occlusion.
Who it may be relevant to
Registry conditions: Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia, Pulmonary Hypertension. Basic parameters: 18 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses and standard of care control group

Detailed description

The purpose of this study is to demonstrate that the FETO procedure increases the neonatal survival to discharge and reduces long-term morbidity rates in fetuses found to have intrathoracic herniation of the liver with LCDH and o/e LHR \< 30% or RCDH and o/e LHR \< 45 % with intrathoracic liver herniation when compared to those that receive standard of care management that have comparable defects for side and fetal lung volumes estimates and intrathoracic liver herniation.

Interventions

  • Device FETO, Fetal Endoluminal Tracheal Occlusion
    Fetal Endoluminal Tracheal Occlusion with Balloon placement for fetuses with congenital diaphragmatic hernia

Primary outcome measures

  • Change lung growth on prenatal imaging [Time frame: prenatal period up to 40 weeks gestation]
Secondary outcome measures (1)
  • Change survival in the severe congenital diaphragmatic hernia subgroup in intervention group [Time frame: 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Cincinnati Children's Hospital Medical Center (CCHMC) — Cincinnati

Identifiers

NCT: NCT07187206 · 2025-0362

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗