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

NCT07166172 | Recruiting DMC FDA Device

• 1 other identifier: IRB00495298
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This registry study aims to confirm that FETO increases neonatal survival to discharge and reduces long-term morbidity in fetuses with isolated left CDH and o/e LHR \< 30%, or isolated right CDH and o/e LHR ≤ 45%, compared to those receiving standard care. This prospective registry plans to enroll 80 pregnant women (40 treatment/40 control) with fetuses diagnosed with isolated CDH, and the children will be followed for up to 24 months.

Conditions

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

Keywords

Fetoscopic Endoluminal Tracheal Occlusion

Outcome Measures

Primary Outcomes (4)

• Number of successful placement of FETO device

  10-60 minutes after surgery begins

• Number of successful removal of FETO device

  Immediately after the procedure (about 1 hour after start of surgery)

• Number of FETO procedure complications

  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.

  End of study (24 months)

• Number of neonates that survived

  Neonatal survival to discharge

  From delivery to hospital discharge

Secondary Outcomes (48)

• Number of infants that survived

  6 months

• Number of infants that survived

  12 months

• Number of infants that survived

  18 months

• Number of infants that survived

  24 months

• Number of infants that show presence of pulmonary hypertension

  6 months

Study Arms (2)

Fetal Treatment Arm (FETO Group)

EXPERIMENTAL

Device: Fetal Treatment Arm (FETO Group)

Expectant Management Arm (Control Group)

NO INTERVENTION

Standard of care treatment for babies with congenital diaphragmatic hernia.

Interventions

Fetal Treatment Arm (FETO Group) DEVICE

Participants will undergo FETO surgery between 27 weeks + 0 days to 29 weeks + 6 days gestation. The FETO intervention involves two procedures: (1) inserting a balloon into the fetal trachea, and (2) removing the balloon before delivery. After the first FETO procedure, participants will be monitored weekly by ultrasound. Removal of the balloon will be performed at 34 weeks + 0 days to 34 weeks + 6 days gestation. Planned delivery will occur after 37 weeks. The follow-up phase will be conducted from birth to 24 months of age.

Also known as: Fetal Endoluminal Tracheal Occlusion (FETO)

Fetal Treatment Arm (FETO Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Inability to reside within 30 minutes of Johns Hopkins Hospital Center for Fetal Therapy.
• 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 Johns Hopkins Hospital Center for Fetal Therapy.
• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• KARL STORZ Endoscopy-America, Inc.: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Hernias, Diaphragmatic, Congenital; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ahmet Baschat, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmet Baschat, MD

CONTACT

410-502-6561; abascha1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 10, 2025
• Study Start: June 23, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2031
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)