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Registry Study for FETO in Severe Left and Right CDH

This study is a registry designed to learn more about a fetal surgery called Fetoscopic Endoluminal Tracheal Occlusion (FETO) for babies with severe congenital diaphragmatic hernia (CDH). CDH is a condition where a baby's diaphragm (the muscle that separates the chest and abdomen) doesn't form completely. The study will look at how well the FETO procedure works in increasing a baby's survival and reducing long-term health problems compared to standard care. You may be able to join if you are pregnant, at least 18 years old, carrying one baby, and your baby has isolated left CDH with a specific lung measurement (o/e LHR < 30%) or isolated right CDH with a specific lung measurement (o/e LHR ≤ 45%). The study aims to enroll 80 pregnant women and will follow the children for up to 24 months. The current status of this study is unclear.

Study design
This is an interventional registry study planning to enroll 80 pregnant women (40 receiving FETO and 40 receiving standard care).
What's involved
If you are in the FETO group, you would undergo two procedures: inserting a balloon into the fetal trachea and removing it before delivery. The children will be followed for up to 24 months.
Compensation
Not stated in the trial record.
Follow-up
Children in this study will be followed for up to 24 months after birth.

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

NCT07166172

Prospective Registry for Long-term Outcomes Following FETO in Severe Left and Right CDH

Recruiting
NAAges 18+InterventionalTreatment
Johns Hopkins University
~80 participants
Updated 2026-04-23 on ClinicalTrials.gov
What's tested:Fetal Treatment Arm (FETO Group)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of successful placement of FETO device
Measured over 10-60 minutes after surgery begins
+3 more outcomes measured

Conditions

Congenital Diaphragmatic Hernia
Congenital Abnormalities
Neonatal Diseases and Abnormalities
Hernia, DIaphragmatic, Congenital
Internal Hernia
Hernia
Pathological Conditions, Anatomical
Pathological Conditions, Signs and Symptoms

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Congenital Diaphragmatic Hernia

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Ahmet Baschat, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Ahmet Baschat, MD
[email protected]
410-502-6561
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Pregnant women age 18 years and older
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 gestation.
Gestational age at enrollment is prior to 29 weeks + 6 days gestation.
Intrathoracic liver herniation:
Isolated left CDH with o/e LHR \< 30% at enrollment (18wks + 0 days to 29wks + 5 days gestation).
Isolated right CDH with o/e LHR ≤ 45% at enrollment (18wks + 0 days to 29wks + 5 days gestation).
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 of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa.
Psychosocial ineligibility, precluding consent:
Bilateral CDH, isolated left sided CDH with O/E LHR ≥ 30% (18wks + 0 days to 29wks + 5 days gestation), isolated right sided CDH with O/E LHR \> 45% (18wks + 0 days to 29wks + 5 days gestation), 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.

What this trial measures

  • Number of successful placement of FETO device10-60 minutes after surgery begins
  • Number of successful removal of FETO deviceImmediately after the procedure (about 1 hour after start of surgery)
  • Number of FETO procedure complicationsEnd of study (24 months)

    Complications include: Failure FETO insertion procedure, FETO device dislodgement potentially requiring a second FETO insertion, Fetal intraoperative injury, Procedural hemorrhage, Bleeding from insertion site or Abruptions, Post-procedural hemorrhage PPROM, Preterm delivery, Chorioamnion separation, Chorioamnionitis, Polyhydramnios, Oligohydramnios, Emergent removal due to obstetrical complication, Failed percutaneous or fetoscopic removal requiring cesarean section or exit procedure for removal, Neonatal death due to asphyxia if delivery before FETO removal, and Non-reassuring fetal heart rate monitoring.

  • Number of neonates that survivedFrom delivery to hospital discharge

    Neonatal survival to discharge