Clinical Trial: Fetal Tracheal Occlusion in Severe Diaphragmatic Hernia: a Randomized Trial
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Tracheal Occlusion Guided by Percutaneous Fetoscopy in Fetuses With Severe Isolated Congenital Diaphragmatic Hernia
Brief 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 Summary:
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).
Sponsor: University of Sao Paulo General Hospital
Current Primary Outcome: Survival rate [ Time Frame: 1 year ]
Noenatal survival rate which includes percentage of newborns that survive up to 30 days of life.
Infant survival rate which includes percentage of newborns that survive up to one year of life. Outcome measurement will be assessed up to one year after birth.
Original Primary Outcome: Same as current
Current Secondary Outcome: Postnatal pulmonary arterial hypertension [ Time Frame: 30 days of life ]
Original Secondary Outcome: Same as current
Information By: University of Sao Paulo General Hospital
Dates:
Date Received: February 21, 2011
Date Started: May 2008
Date Completion: December 2011
Last Updated: February 23, 2011
Last Verified: February 2011
