Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
70 participants
INTERVENTIONAL
2014-06-30
2016-12-31
Brief Summary
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We hypothesize that performing an earlier FETO, between 22-24 weeks, fetuses with severe form of CDH will have a better fetal pulmonary response and higher chance of surviving.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard FETO
Group of fetus that undergo fetal endoscopic tracheal occlusion between 26 0/7 weeks and 28 6/7 weeks.
Fetal endoscopic tracheal occlusion
FETO will be performed by placing a detachable balloon inside fetal trachea
Early FETO
Group of fetus that undergo fetal endoscopic tracheal occlusion between 22 0/7 weeks and 24 6/7 weeks.
Fetal endoscopic tracheal occlusion
FETO will be performed by placing a detachable balloon inside fetal trachea
Interventions
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Fetal endoscopic tracheal occlusion
FETO will be performed by placing a detachable balloon inside fetal trachea
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Gestational age established by last menstruation and/or first trimester ultrasonography;
* Prenatal diagnosis of congenital diaphragmatic hernia before 24 weeks of gestation
* Severe congenital diaphragmatic hernia (at 24 weeks, lung-to-head ratio \<1.0 and at least 1/3 of the liver herniated into the fetal thorax)
* written informed consent (by the patient)
Exclusion Criteria
* Preterm labor before randomization
22 Weeks
28 Weeks
ALL
No
Sponsors
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University of Sao Paulo
OTHER
University of Sao Paulo General Hospital
OTHER
Responsible Party
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Principal Investigators
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Rodrigo Ruano, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Faculdade de Medicina da Universidade de Sao Paulo
Locations
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Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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References
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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.
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.
Ruano R, da Silva MM, Campos JA, Papanna R, Moise K Jr, Tannuri U, Zugaib M. Fetal pulmonary response after fetoscopic tracheal occlusion for severe isolated congenital diaphragmatic hernia. Obstet Gynecol. 2012 Jan;119(1):93-101. doi: 10.1097/AOG.0b013e31823d3aea.
Harrison MR, Keller RL, Hawgood SB, Kitterman JA, Sandberg PL, Farmer DL, Lee H, Filly RA, Farrell JA, Albanese CT. A randomized trial of fetal endoscopic tracheal occlusion for severe fetal congenital diaphragmatic hernia. N Engl J Med. 2003 Nov 13;349(20):1916-24. doi: 10.1056/NEJMoa035005.
Jani JC, Nicolaides KH, Gratacos E, Valencia CM, Done E, Martinez JM, Gucciardo L, Cruz R, Deprest JA. Severe diaphragmatic hernia treated by fetal endoscopic tracheal occlusion. Ultrasound Obstet Gynecol. 2009 Sep;34(3):304-10. doi: 10.1002/uog.6450.
Deprest J, Gratacos E, Nicolaides KH; FETO Task Group. Fetoscopic tracheal occlusion (FETO) for severe congenital diaphragmatic hernia: evolution of a technique and preliminary results. Ultrasound Obstet Gynecol. 2004 Aug;24(2):121-6. doi: 10.1002/uog.1711.
Other Identifiers
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8353/12
Identifier Type: -
Identifier Source: org_study_id