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

NCT07166172 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-04-23

No results posted yet for this study

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

Interventions

DEVICE

Fetal Treatment Arm (FETO Group)

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.

Sponsors & Collaborators

Principal Investigators

  • Ahmet Baschat, MD · Johns Hopkins University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-23
Primary Completion
2029-12-01
Completion
2031-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07166172 on ClinicalTrials.gov