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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of Sao Paulo General Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ministry of Health, Brazil
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01302977
First received: February 21, 2011
Last updated: February 23, 2011
Last verified: February 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Congenital Diaphragmatic Hernia
Congenital Abnormality
 Procedure: Fetal tracheal occlusion
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tracheal Occlusion Guided by Percutaneous Fetoscopy in Fetuses With Severe Isolated Congenital Diaphragmatic Hernia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Survival rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • Postnatal pulmonary arterial hypertension [ Time Frame: 30 days of life ] [ Designated as safety issue: No ]
    Postnatal pulmonary arterial hypertension will be assessed up to 30 days of life according to the echocardiographic findings.


Estimated Enrollment: 36
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)
Arms Assigned Interventions
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

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).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302977

Locations
Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo Recruiting
Sao Paulo, Brazil, 05403010
Contact: Rodrigo Ruano, MD, PhD     5511-30696445     rodrigoruano@usp.br    
Contact: Nanci Valeis     5511-3069-6442 r. 29     nanci.valeis@hcnet.usp.br    
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            
Sponsors and Collaborators
University of Sao Paulo General Hospital
Ministry of Health, Brazil
Investigators
Principal Investigator: Rodrigo Ruano, MD, PhD Faculdade de Medicina da Universidade de Sao Paulo
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Rodrigo Ruano, MD, PhD, Faculdade de Medicina da Universidade de Sao Paulo
ClinicalTrials.gov Identifier: NCT01302977     History of Changes
Other Study ID Numbers: CAPPesq 1087/07
Study First Received: February 21, 2011
Last Updated: February 23, 2011
Health Authority: Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo General Hospital:
Congenital diaphragmatic hernia
Fetal anomalies

Additional relevant MeSH terms:
Congenital Abnormalities
Hernia
Hernia, Diaphragmatic
Hernia, Hiatal
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 16, 2013