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

Primary Purpose

Congenital Diaphragmatic Hernia, Congenital Abnormality

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Fetal tracheal occlusion
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Diaphragmatic Hernia focused on measuring Congenital diaphragmatic hernia, Fetal anomalies

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Fetal intervention

Control

Arm Description

Composed of fetuses that undergo to fetal tracheal occlusion at 26-28 weeks.

Composed of fetuses that do not undergo fetal intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Postnatal pulmonary arterial hypertension
Postnatal pulmonary arterial hypertension will be assessed up to 30 days of life according to the echocardiographic findings.

Full Information

First Posted
February 21, 2011
Last Updated
February 23, 2011
Sponsor
University of Sao Paulo General Hospital
Collaborators
Ministry of Health, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT01302977
Brief Title
Fetal Tracheal Occlusion in Severe Diaphragmatic Hernia: a Randomized Trial
Acronym
BRAFETO
Official Title
Tracheal Occlusion Guided by Percutaneous Fetoscopy in Fetuses With Severe Isolated Congenital Diaphragmatic Hernia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2008 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Ministry of Health, Brazil

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Diaphragmatic Hernia, Congenital Abnormality
Keywords
Congenital diaphragmatic hernia, Fetal anomalies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fetal intervention
Arm Type
Experimental
Arm Description
Composed of fetuses that undergo to fetal tracheal occlusion at 26-28 weeks.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Composed of fetuses that do not undergo fetal intervention
Intervention Type
Procedure
Intervention Name(s)
Fetal tracheal occlusion
Other Intervention Name(s)
FETO, TO
Intervention Description
Insertion of a detachable balloon inside fetal trachea by percutaneous fetoscopy
Primary Outcome Measure Information:
Title
Survival rate
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Postnatal pulmonary arterial hypertension
Description
Postnatal pulmonary arterial hypertension will be assessed up to 30 days of life according to the echocardiographic findings.
Time Frame
30 days of life

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo Ruano, MD, PhD
Organizational Affiliation
Faculdade de Medicina da Universidade de Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05403010
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo Ruano, MD, PhD
Phone
5511-30696445
Email
rodrigoruano@usp.br
First Name & Middle Initial & Last Name & Degree
Nanci Valeis
Phone
5511-3069-6442 r. 29
Email
nanci.valeis@hcnet.usp.br
First Name & Middle Initial & Last Name & Degree
Rodrigo Ruano, MD, PhD
First Name & Middle Initial & Last Name & Degree
Marcos M Silva, MD, PhD
First Name & Middle Initial & Last Name & Degree
Uenis Tannuri, MD, PhD
First Name & Middle Initial & Last Name & Degree
Marcelo Zugaib, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
20389048
Citation
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.
Results Reference
background
PubMed Identifier
22170862
Citation
Ruano R, Yoshisaki CT, da Silva MM, Ceccon ME, Grasi MS, Tannuri U, Zugaib M. A randomized controlled trial of fetal endoscopic tracheal occlusion versus postnatal management of severe isolated congenital diaphragmatic hernia. Ultrasound Obstet Gynecol. 2012 Jan;39(1):20-7. doi: 10.1002/uog.10142. Epub 2011 Dec 14.
Results Reference
derived

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Fetal Tracheal Occlusion in Severe Diaphragmatic Hernia: a Randomized Trial

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