Back to search results

FETO for Congenital Diaphragmatic Hernia (CDH)

This study is testing a procedure called Fetal Endoluminal Tracheal Occlusion (FETO) for babies diagnosed with congenital diaphragmatic hernia (CDH) before birth. CDH is a condition where a baby's diaphragm (the muscle that separates the chest and abdomen) doesn't form completely, allowing organs to move into the chest. The FETO procedure involves placing a balloon in the baby's windpipe while still in the womb. Researchers want to see if FETO helps babies with CDH survive longer and have fewer long-term health problems compared to standard care. You might be able to join if you are a pregnant woman between 18 and 50 years old, carrying one baby, and your baby has a specific type of CDH with the liver in the chest. The study will measure changes in your baby's lung growth before birth to see if the treatment is working. The study is currently unclear on its recruitment status.

Study design
This interventional study plans to enroll 75 participants. It compares the FETO procedure with standard care for babies with CDH.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Lung growth will be measured during the prenatal period up to 40 weeks gestation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07187206

Safety and Efficacy of FETO in CDH Phase III

Recruiting
PHASE3Ages 18–50InterventionalTreatment
Children's Hospital Medical Center, Cincinnati
~75 participants
Updated 2025-09-22 on ClinicalTrials.gov
What's tested:FETO, Fetal Endoluminal Tracheal Occlusion

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change lung growth on prenatal imaging
Measured over prenatal period up to 40 weeks gestation

Conditions

Congenital Diaphragmatic Hernia
Pulmonary Hypoplasia
Pulmonary Hypertension

Explore related trials

Congenital Diaphragmatic HerniaPulmonary HypertensionPulmonary HypoplasiaKaryotype

Where it's being run

1 sites across 1 states
Ohio1

Who to contact

Foong-Yen Lim, MD
[email protected]
(513) 636-6259
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change lung growth on prenatal imagingprenatal period up to 40 weeks gestation

    Change in o/eLHR and other prenatal imaging tests