NCT01302977

Fetal Tracheal Occlusion in Severe Diaphragmatic Hernia: a Randomized Trial

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Congenital Diaphragmatic Hernia
• Congenital Abnormality

Interventions

Type	Name	Description
PROCEDURE	Fetal tracheal occlusion	Insertion of a detachable balloon inside fetal trachea by percutaneous fetoscopy

Timeline

• Start date: 2008-05-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-02-24
• Last updated: 2011-02-24

Locations

1 site across 1 country: Brazil