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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT07166172
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jun 23, 2025
Status verified
Apr 2026
Primary completion
Dec 1, 2029
Completion
Dec 1, 2031

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Fetal Treatment Arm (FETO Group)
  • No Intervention: Expectant Management Arm (Control Group)
    Standard of care treatment for babies with congenital diaphragmatic hernia.

Primary Outcome Measure

Number of successful placement of FETO device [ Time Frame: 10-60 minutes after surgery begins ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21287
Ahmet A. Baschat, MD
[email protected]
410-502-6561

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By research site
Johns Hopkins Hospital· Baltimore, MD

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