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

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ClinicalTrials.gov Identifier: NCT01302977
Recruitment Status : Unknown
Verified February 2011 by University of Sao Paulo General Hospital.
Recruitment status was:  Recruiting
First Posted : February 24, 2011
Last Update Posted : February 24, 2011
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Congenital Diaphragmatic Hernia Congenital Abnormality Procedure: Fetal tracheal occlusion Phase 2

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).

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
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
Study Start Date : May 2008
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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    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
Principal Investigator: Rodrigo Ruano, MD, PhD Faculdade de Medicina da Universidade de Sao Paulo
More Information

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
First Posted: February 24, 2011    Key Record Dates
Last Update Posted: February 24, 2011
Last Verified: February 2011

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

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