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Fetal Tracheal Occlusion in Severe Diaphragmatic Hernia: a Randomized Trial — BRAFETO  

Congenital Diaphragmatic Hernia Clinical Trial

Official title:
Tracheal Occlusion Guided by Percutaneous Fetoscopy in Fetuses With Severe Isolated Congenital Diaphragmatic Hernia

Clinical Trial Summary

The neonatal mortality rate in cases with severe isolated congenital diaphragmatic hernia is higher than 90% due to severe pulmonary hypoplasia. Many studies have suggested that fetal tracheal occlusion may increase lung volumes and therefore reducing the risk for severe pulmonary hypoplasia and by consequence the risk for neonatal death.

The main objective of the present study is to evaluate if fetal tracheal occlusion improves survival rate in those cases that are followed in our hospital, by conducing a randomized trial.

Clinical Trial Description

Fetuses will be randomly allocated in two groups: 1. for fetal tracheal occlusion at 26-28 weeks (FETO group) or 2. Postnatal therapy only (Control)

Main outcome: Survival rate in both groups Second outcomes: Postnatal diagnosis of severe pulmonary arterial hypertension, percentage of newborns in each group that will have clinical conditions for neonatal surgical repair of the diaphragmatic defect, fetal lung responses (increase of fetal lung size), maternal and obstetrical complications (prematurity, preterm rupture of the membranes, maternal hemorrhage and infection). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01302977
Study type Interventional
Source University of Sao Paulo General Hospital
Contact
Status Unknown status
Phase Phase 2
Start date May 2008
Completion date December 2011
View Details
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