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Clinical Trial

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

NCT: NCT00881660 · COMPLETED

NCT IDNCT00881660
StatusCOMPLETED
Start Date2012-02-21
Completion2023-04-11
SponsorMichael A Belfort (OTHER)
First posted
Last updated

Brief 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.

Frequently Asked Questions

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

Fetal Endotracheal Occlusion (FETO) in Severe and Extremely Severe Congenital Diaphragmatic Hernia is a clinical trial registered under NCT00881660. Current status: COMPLETED.

What is the status of NCT00881660?

The current status of NCT00881660 (Fetal Endotracheal Occlusion (FETO) in Severe and Extremely Severe Congenital Diaphragmatic Hernia) is: COMPLETED.

When did Fetal Endotracheal Occlusion (FETO) in Severe and Extremely Severe Congenital Diaphragmatic Hernia start?

Fetal Endotracheal Occlusion (FETO) in Severe and Extremely Severe Congenital Diaphragmatic Hernia started on 2012-02-21.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.

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