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Early FETO for Severe Congenital Diaphragmatic Hernia

Primary Purpose

Congenital Diaphragmatic Hernia

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Fetal endoscopic 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, fetoscopy, fetal endoscopic tracheal occlusion, pulmonary hypoplasia, fetal surgery, fetal lung

Eligibility Criteria

22 Weeks - 28 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Fetuses with isolated congenital diaphragmatic hernia (normal fetal karyotype and absence of any associated structural anomaly);
  • 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 premature rupture of the membranes before randomization
  • Preterm labor before randomization

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard FETO

Early FETO

Arm Description

Group of fetus that undergo fetal endoscopic tracheal occlusion between 26 0/7 weeks and 28 6/7 weeks.

Group of fetus that undergo fetal endoscopic tracheal occlusion between 22 0/7 weeks and 24 6/7 weeks.

Outcomes

Primary Outcome Measures

Infant survival rate
Percentage of survivors at 6 months of life

Secondary Outcome Measures

Postnatal severe pulmonary arterial hypertension (PAH)
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).
Respiratory morbidity
Need for ventilatory support and/or oxygen dependency.

Full Information

First Posted
November 14, 2012
Last Updated
December 16, 2013
Sponsor
University of Sao Paulo General Hospital
Collaborators
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01731509
Brief Title
Early FETO for Severe Congenital Diaphragmatic Hernia
Official Title
"Early" Versus "Standard" Fetal Endoscopic Tracheal Occlusion for Severe Congenital Diaphragmatic Hernia - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Diaphragmatic Hernia
Keywords
congenital diaphragmatic hernia, fetoscopy, fetal endoscopic tracheal occlusion, pulmonary hypoplasia, fetal surgery, fetal lung

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard FETO
Arm Type
Active Comparator
Arm Description
Group of fetus that undergo fetal endoscopic tracheal occlusion between 26 0/7 weeks and 28 6/7 weeks.
Arm Title
Early FETO
Arm Type
Experimental
Arm 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(s)
Fetal endoscopic tracheal occlusion
Other Intervention Name(s)
FETO or fetal endoscopic traqueal occlusion
Intervention Description
FETO will be performed by placing a detachable balloon inside fetal trachea
Primary Outcome Measure Information:
Title
Infant survival rate
Description
Percentage of survivors at 6 months of life
Time Frame
6 months of life
Secondary Outcome Measure Information:
Title
Postnatal severe pulmonary arterial hypertension (PAH)
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).
Time Frame
30 days of life
Title
Respiratory morbidity
Description
Need for ventilatory support and/or oxygen dependency.
Time Frame
6 months of life
Other Pre-specified Outcome Measures:
Title
obstetrical complications (morbidity)
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
Time Frame
pregnancy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Weeks
Maximum Age & Unit of Time
28 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Fetuses with isolated congenital diaphragmatic hernia (normal fetal karyotype and absence of any associated structural anomaly); 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 premature rupture of the membranes before randomization Preterm labor before randomization
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rodrigo Ruano, MD PhD
Phone
(5511)95739188
Email
rodrigoruano@usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Eugenia MA Salustiano, RN
Phone
(5511)2661-6209
Email
eugeniaassuncao@hotmail.com
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
05403-010
Country
Brazil

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
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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
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PubMed Identifier
22183216
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.
Results Reference
background
PubMed Identifier
14614166
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.
Results Reference
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PubMed Identifier
19658113
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.
Results Reference
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PubMed Identifier
15287047
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.
Results Reference
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Early FETO for Severe Congenital Diaphragmatic Hernia

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