Fetal Tracheal Occlusion in Severe Diaphragmatic Hernia: a Randomized Trial (BRAFETO)
Recruitment status was: Recruiting
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.
|Congenital Diaphragmatic Hernia Congenital Abnormality||Procedure: Fetal tracheal occlusion||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Tracheal Occlusion Guided by Percutaneous Fetoscopy in Fetuses With Severe Isolated Congenital Diaphragmatic Hernia|
- 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.
- Postnatal pulmonary arterial hypertension [ Time Frame: 30 days of life ]Postnatal pulmonary arterial hypertension will be assessed up to 30 days of life according to the echocardiographic findings.
|Study Start Date:||May 2008|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Experimental: Fetal intervention
Composed of fetuses that undergo to fetal tracheal occlusion at 26-28 weeks.
Procedure: Fetal tracheal occlusion
Insertion of a detachable balloon inside fetal trachea by percutaneous fetoscopy
Other Name: FETO, TO
No Intervention: Control
Composed of fetuses that do not undergo fetal intervention
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302977
|Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo||Recruiting|
|Sao Paulo, Brazil, 05403010|
|Contact: Rodrigo Ruano, MD, PhD 5511-30696445 firstname.lastname@example.org|
|Contact: Nanci Valeis 5511-3069-6442 r. 29 email@example.com|
|Principal Investigator: Rodrigo Ruano, MD, PhD|
|Sub-Investigator: Marcos M Silva, MD, PhD|
|Sub-Investigator: Uenis Tannuri, MD, PhD|
|Sub-Investigator: Marcelo Zugaib, MD, PhD|
|Principal Investigator:||Rodrigo Ruano, MD, PhD||Faculdade de Medicina da Universidade de Sao Paulo|