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

February 23, 2011 updated by: University of Sao Paulo General Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403010
        • Recruiting
        • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
        • Contact:
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • FETO, TO
No Intervention: Control
Composed of fetuses that do not undergo fetal intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Ministry of Health, Brazil

Investigators

  • Principal Investigator: Rodrigo Ruano, MD, PhD, Faculdade de Medicina da Universidade de Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

February 21, 2011

First Submitted That Met QC Criteria

February 23, 2011

First Posted (Estimate)

February 24, 2011

Study Record Updates

Last Update Posted (Estimate)

February 24, 2011

Last Update Submitted That Met QC Criteria

February 23, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAPPesq 1087/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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