Fetal Tracheal Occlusion in Severe Diaphragmatic Hernia: a Randomized Trial

Congenital Diaphragmatic Hernia Clinical Trial

— BRAFETO  

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01302977
• Other study ID #: CAPPesq 1087/07
• Status: Unknown status
• Phase: Phase 2
• First received: February 21, 2011
• Last updated: February 23, 2011
• Start date: May 2008
• Est. completion date: December 2011

Study information

• Verified date: February 2011
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 36
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• ultrasound diagnosis of congenital diaphragmatic hernia

• fetuses at gestational age between 24 and 28 weeks

• absence of chromosomal and/or other structural anomalies (isolated congenital diaphragmatic hernia)

• severe congenital diaphragmatic hernia defined by lung-head ratio < 1.0 and more than 1/3 of liver herniated into fetal thorax and observed/expected fetal total lung volume < 0.35

• patient's consent to participate in the present study

Exclusion Criteria:

• Patient's refusal to participate in the study after allocation

• Preterm labor diagnosed before the procedure

• Preterm rupture of membranes before fetal intervention

Related Conditions & MeSH terms

• Congenital Abnormalities
• Congenital Abnormality
• Congenital Diaphragmatic Hernia
• Hernia
• Hernia, Diaphragmatic
• Hernias, Diaphragmatic, Congenital

Intervention

Procedure:
• Fetal tracheal occlusion
Insertion of a detachable balloon inside fetal trachea by percutaneous fetoscopy

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Ruano R, Duarte SA, Pimenta EJ, Takashi E, da Silva MM, Tannuri U, Zugaib M. Comparison between fetal endoscopic tracheal occlusion using a 1.0-mm fetoscope and prenatal expectant management in severe congenital diaphragmatic hernia. Fetal Diagn Ther. 2011;29(1):64-70. doi: 10.1159/000311944. Epub 2010 Apr 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate	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.	1 year
Secondary	Postnatal pulmonary arterial hypertension	Postnatal pulmonary arterial hypertension will be assessed up to 30 days of life according to the echocardiographic findings.	30 days of life