<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01731509</url>
  </required_header>
  <id_info>
    <org_study_id>8353/12</org_study_id>
    <nct_id>NCT01731509</nct_id>
  </id_info>
  <brief_title>Early FETO for Severe Congenital Diaphragmatic Hernia</brief_title>
  <official_title>&quot;Early&quot; Versus &quot;Standard&quot; Fetal Endoscopic Tracheal Occlusion for Severe Congenital Diaphragmatic Hernia - a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Sao Paulo General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Congenital diaphragmatic hernia (CDH) is associated high mortality and morbidity, mainly in&#xD;
      those cases with severe forms where there are extremely reduced lung volumes, liver&#xD;
      herniation and decreased abnormal pulmonary vascularization. Fetal endoscopic tracheal&#xD;
      occlusion performed between 26 and 30 weeks (standard FETO) has been shown to increase fetal&#xD;
      pulmonary size and vascularity, and to improve infant survival in isolated severe CDH. Fetal&#xD;
      pulmonary response followed FETO can be used to predict outcome and is dependent on the size&#xD;
      of the fetal lung prior to the procedure.&#xD;
&#xD;
      We hypothesize that performing an earlier FETO, between 22-24 weeks, fetuses with severe form&#xD;
      of CDH will have a better fetal pulmonary response and higher chance of surviving.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We pretend to investigate if &quot;early FETO&quot; will improve the survival rate and the fetal&#xD;
      pulmonary response, by conducting a randomized controlled trial comparing the results with&#xD;
      those fetuses that undergo to &quot;standard FETO&quot; (between 26-28 weeks).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Infant survival rate</measure>
    <time_frame>6 months of life</time_frame>
    <description>Percentage of survivors at 6 months of life</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postnatal severe pulmonary arterial hypertension (PAH)</measure>
    <time_frame>30 days of life</time_frame>
    <description>Severe PAH will be considered when the neonate presents with profound cyanosis associated with echocardiographic continuous right-to-left shunting through a persistent 'ductus arteriosus' and a persistent difference in pre- to postductal saturation gradient &gt;20%, despite the use of intake Nitric Oxide (iNO).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory morbidity</measure>
    <time_frame>6 months of life</time_frame>
    <description>Need for ventilatory support and/or oxygen dependency.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>obstetrical complications (morbidity)</measure>
    <time_frame>pregnancy</time_frame>
    <description>Preterm premature rupture of the membranes (&lt;37 weeks)&#xD;
Extremely preterm premature rupture of the membranes (&lt;32 weeks)&#xD;
Preterm delivery (birth &lt;37 weeks of gestation)&#xD;
Extremely preterm delivery (birth &lt;32 weeks)&#xD;
Placental abruption&#xD;
Chorioamnionitis and maternal infection</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Congenital Diaphragmatic Hernia</condition>
  <arm_group>
    <arm_group_label>Standard FETO</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group of fetus that undergo fetal endoscopic tracheal occlusion between 26 0/7 weeks and 28 6/7 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Early FETO</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group of fetus that undergo fetal endoscopic tracheal occlusion between 22 0/7 weeks and 24 6/7 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fetal endoscopic tracheal occlusion</intervention_name>
    <description>FETO will be performed by placing a detachable balloon inside fetal trachea</description>
    <arm_group_label>Early FETO</arm_group_label>
    <arm_group_label>Standard FETO</arm_group_label>
    <other_name>FETO or fetal endoscopic traqueal occlusion</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fetuses with isolated congenital diaphragmatic hernia (normal fetal karyotype and&#xD;
             absence of any associated structural anomaly);&#xD;
&#xD;
          -  Gestational age established by last menstruation and/or first trimester&#xD;
             ultrasonography;&#xD;
&#xD;
          -  Prenatal diagnosis of congenital diaphragmatic hernia before 24 weeks of gestation&#xD;
&#xD;
          -  Severe congenital diaphragmatic hernia (at 24 weeks, lung-to-head ratio &lt;1.0 and at&#xD;
             least 1/3 of the liver herniated into the fetal thorax)&#xD;
&#xD;
          -  written informed consent (by the patient)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preterm premature rupture of the membranes before randomization&#xD;
&#xD;
          -  Preterm labor before randomization&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Weeks</minimum_age>
    <maximum_age>28 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rodrigo Ruano, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculdade de Medicina da Universidade de Sao Paulo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rodrigo Ruano, MD PhD</last_name>
    <phone>(5511)95739188</phone>
    <email>rodrigoruano@usp.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Eugenia MA Salustiano, RN</last_name>
    <phone>(5511)2661-6209</phone>
    <email>eugeniaassuncao@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05403-010</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>20389048</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>22170862</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22183216</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>14614166</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19658113</PMID>
  </reference>
  <reference>
    <citation>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. Erratum In: Ultrasound Obstet Gynecol. 2004 Oct;24(5):594.</citation>
    <PMID>15287047</PMID>
  </reference>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>December 16, 2013</last_update_submitted>
  <last_update_submitted_qc>December 16, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 17, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>congenital diaphragmatic hernia</keyword>
  <keyword>fetoscopy</keyword>
  <keyword>fetal endoscopic tracheal occlusion</keyword>
  <keyword>pulmonary hypoplasia</keyword>
  <keyword>fetal surgery</keyword>
  <keyword>fetal lung</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernias, Diaphragmatic, Congenital</mesh_term>
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Diaphragmatic</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01731509
org study id: 8353/12
nct id: NCT01731509
lead sponsor: 
collaborator: 
has dmc: Yes
Congenital diaphragmatic hernia (CDH) is associated high mortality and morbidity, mainly in
      those cases with severe forms where there are extremely reduced lung volumes, liver
      herniation and decreased abnormal pulmonary vascularization. Fetal endoscopic tracheal
      occlusion performed between 26 and 30 weeks (standard FETO) has been shown to increase fetal
      pulmonary size and vascularity, and to improve infant survival in isolated severe CDH. Fetal
      pulmonary response followed FETO can be used to predict outcome and is dependent on the size
      of the fetal lung prior to the procedure.

      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.
We pretend to investigate if "early FETO" will improve the survival rate and the fetal
      pulmonary response, by conducting a randomized controlled trial comparing the results with
      those fetuses that undergo to "standard FETO" (between 26-28 weeks).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Infant survival rate
time frame: 6 months of life
description: Percentage of survivors at 6 months of life
measure: Postnatal severe pulmonary arterial hypertension (PAH)
time frame: 30 days of life
description: Severe PAH will be considered when the neonate presents with profound cyanosis associated with echocardiographic continuous right-to-left shunting through a persistent 'ductus arteriosus' and a persistent difference in pre- to postductal saturation gradient >20%, despite the use of intake Nitric Oxide (iNO).
measure: Respiratory morbidity
time frame: 6 months of life
description: Need for ventilatory support and/or oxygen dependency.
measure: obstetrical complications (morbidity)
time frame: pregnancy
description: Preterm premature rupture of the membranes (<37 weeks)
Extremely preterm premature rupture of the membranes (<32 weeks)
Preterm delivery (birth <37 weeks of gestation)
Extremely preterm delivery (birth <32 weeks)
Placental abruption
Chorioamnionitis and maternal infection
arm group label: Standard FETO
arm group type: Active Comparator
description: Group of fetus that undergo fetal endoscopic tracheal occlusion between 26 0/7 weeks and 28 6/7 weeks.
arm group label: Early FETO
arm group type: Experimental
description: Group of fetus that undergo fetal endoscopic tracheal occlusion between 22 0/7 weeks and 24 6/7 weeks.
intervention type: Other
intervention name: Fetal endoscopic tracheal occlusion
description: FETO will be performed by placing a detachable balloon inside fetal trachea
arm group label: Early FETO
arm group label: Standard FETO
other name: FETO or fetal endoscopic traqueal occlusion
criteria: 
gender: All
minimum age: 22 Weeks
maximum age: 28 Weeks
healthy volunteers: No
last name: Rodrigo Ruano, MD PhD
role: Principal Investigator
affiliation: Faculdade de Medicina da Universidade de Sao Paulo
last name: Rodrigo Ruano, MD PhD
phone: (5511)95739188
email: rodrigoruano@usp.br
last name: Eugenia MA Salustiano, RN
phone: (5511)2661-6209
email: eugeniaassuncao@hotmail.com
facility: 
country: Brazil
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.
PMID: 20389048
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.
PMID: 22170862
citation: 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.
PMID: 22183216
citation: 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.
PMID: 14614166
citation: 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.
PMID: 19658113
citation: 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. Erratum In: Ultrasound Obstet Gynecol. 2004 Oct;24(5):594.
PMID: 15287047
responsible party type: Sponsor
mesh term: Hernias, Diaphragmatic, Congenital
mesh term: Hernia
mesh term: Hernia, Diaphragmatic