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Fetal Endotracheal Occlusion (FETO) in Severe and Extremely Severe Congenital Diaphragmatic Hernia

NCT00881660 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-11-14

No results posted yet for this study

Summary

Congenital diaphragmatic hernia (CDH) occurs when the diaphragm fails to fully fuse and leaves a portal through which abdominal structures can migrate into the thorax. In the more severe cases, the abdominal structures remain in the thoracic cavity and compromise the development of the lungs. Infants born with this defect have a decreased capacity for gas exchange; mortality rates after birth have been reported between 40-60%. Now that CDH can be accurately diagnosed by mid-gestation, a number of strategies have been developed to repair the hernia and promote lung tissue development.

Fetal tracheal occlusion is one technique that temporarily closes the herniated area with the Goldvalve balloon to allow the lungs to develop and increase survival at birth. This is a pilot study of a cohort of fetuses affected by severe CDH that will undergo FETO to demonstrate the feasibility of performing the procedure, managing the pregnancy during the period of tracheal occlusion, and removal of the device prior to delivery at BCM/Texas Children's Hospital (TCH). It is anticipated that fetal tracheal occlusion plug-unplug procedure will improve mortality and morbidity outcomes as compared with current management, but this is not a primary endpoint of the feasibility study. We will perform 20 FETO procedures on fetuses diagnosed prenatally with severe and extremely severe CDH.

Conditions

  • Congenital Diaphragmatic Hernia

Interventions

DEVICE

Goldballoon Detachable Balloon and delivery microcatheter

Between 27+0/7 - 29+ 6/7 weeks gestation for severe CDH and can be as early as 22+0/7 weeks gestational age for those deemed as "extremely severe" cases of CDH, placement of the Goldvalve detachable balloon. Balloon retrieval will be planned for between 32+0/7 and 34+6/7 weeks or no longer than 10 weeks after balloon placement at the discretion of the FETO center.

Sponsors & Collaborators

  • Baylor College of Medicine

    collaborator OTHER

  • Michael A Belfort

    lead OTHER

Principal Investigators

  • Michael Belfort, MD, PhD · Baylor College of Medicine - Texas Children's Hospital

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-21
Primary Completion
2023-04-11
Completion
2023-04-11
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT00881660 on ClinicalTrials.gov