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Fetal Endotracheal Occlusion (FETO) in Severe and Extremely Severe Congenital Diaphragmatic Hernia (FETO)

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ClinicalTrials.gov Identifier: NCT00881660
Recruitment Status : Recruiting
First Posted : April 15, 2009
Last Update Posted : May 15, 2018
Sponsor:
Collaborators:
Baylor College of Medicine
Texas Children's Hospital
Information provided by (Responsible Party):
Michael Belfort, Baylor College of Medicine

Brief Summary:

Congenital diaphragmatic hernia (CDH) occurs when the diaphragm fails to fully fuse and leaves a portal through which abdominal structures can migrate into the thorax. In the more severe cases, the abdominal structures remain in the thoracic cavity and compromise the development of the lungs. Infants born with this defect have a decreased capacity for gas exchange; mortality rates after birth have been reported between 40-60%. Now that CDH can be accurately diagnosed by mid-gestation, a number of strategies have been developed to repair the hernia and promote lung tissue development.

Fetal tracheal occlusion is one technique that temporarily closes the herniated area with the Goldvalve balloon to allow the lungs to develop and increase survival at birth. This is a pilot study of a cohort of fetuses affected by severe CDH that will undergo FETO to demonstrate the feasibility of performing the procedure, managing the pregnancy during the period of tracheal occlusion, and removal of the device prior to delivery at BCM/Texas Children's Hospital (TCH). It is anticipated that fetal tracheal occlusion plug-unplug procedure will improve mortality and morbidity outcomes as compared with current management, but this is not a primary endpoint of the feasibility study. We will perform 20 FETO procedures on fetuses diagnosed prenatally with severe and extremely severe CDH.


Condition or disease Intervention/treatment Phase
Congenital Diaphragmatic Hernia Device: Goldballoon Detachable Balloon and delivery microcatheter Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: A Prospective Study of the Effectiveness of Fetal Endotracheal Occlusion (FETO) in the Management of Severe and Extremely Severe Congenital Diaphragmatic Hernia
Study Start Date : March 2010
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: Fetal Endotracheal Occlusion
Placement and retrieval of the GoldBAL4 or GoldBal2 Detachable balloon using the plug/unplug method, using BALTACCIDBPE100 Delivery Catheter.
Device: Goldballoon Detachable Balloon and delivery microcatheter
Between 27+0/7 - 29+ 6/7 weeks gestation for severe CDH and can be as early as 22+0/7 weeks gestational age for those deemed as "extremely severe" cases of CDH, placement of the Goldvalve detachable balloon. Balloon retrieval will be planned for between 32+0/7 and 34+6/7 weeks or no longer than 10 weeks after balloon placement at the discretion of the FETO center.
Other Names:
  • GOLDBAL4 or GOLDBAL2 Goldballoon
  • BALTACCIBDPE100 delivery microcatheter



Primary Outcome Measures :
  1. 2-year Survival [ Time Frame: 2 years after childbirth. ]
    To assess two-year neonatal survival following FETO.


Secondary Outcome Measures :
  1. Successful completion of surgical procedures/balloon placement [ Time Frame: Up to 10 weeks. ]
    To assess the successful completion of surgical procedures/placement of balloons in fetuses with severe or extremely severe CDH.Case report forms are utilized to record study related data, including any procedural complications such as failed balloon placement or failed balloon retrieval, as well as surgical or anesthesia complications. At least twice a month fetal surveillance will be performed for up to 10 weeks post balloon placement.

  2. Maternal Outcomes- Maternal Morbidity-incidence of preterm delivery [ Time Frame: Up to 6 weeks postpartum ]
    Case report forms are utilized to record study related data through patient's medical chart review. Maternal morbidity will be assessed in terms of incidence of preterm delivery (spontaneous or indicated).

  3. Maternal Outcomes- Maternal Morbidity-incidence of cesarean section [ Time Frame: Up to 6 weeks postpartum ]
    Case report forms are utilized to record study related data through patient's medical chart review. Maternal morbidity will be assessed in terms of incidence of cesarean section rate.

  4. Maternal Outcomes- Maternal Morbidity-length of hospitalization [ Time Frame: Up to 6 weeks postpartum ]
    Case report forms are utilized to record study related data through patient's medical chart review. Maternal morbidity will be assessed in terms of length of hospitalization after the FETO procedure.

  5. Maternal Outcomes- Maternal Morbidity- length of hospitalization after UNPLUG procedure [ Time Frame: Up to 6 weeks postpartum ]
    Case report forms are utilized to record study related data through patient's medical chart review. Maternal morbidity will be assessed in terms of length of hospitalization after balloon removal (UNPLUG)

  6. Maternal Outcomes- Maternal Morbidity- vaginal bleeding [ Time Frame: Up to 6 weeks postpartum ]
    Case report forms are utilized to record study related data through patient's medical chart review. Maternal morbidity will be assessed in terms of incidence of post procedure vaginal bleeding.

  7. Maternal Outcomes- Maternal Morbidity- Placental abruption [ Time Frame: Up to 6 weeks postpartum ]
    Case report forms are utilized to record study related data through patient's medical chart review. Maternal morbidity will be assessed in terms of incidence of post-procedure placental abruption.

  8. Maternal Outcomes- Maternal Morbidity- Rupture of membranes [ Time Frame: Up to 6 weeks postpartum ]
    Case report forms are utilized to record study related data through patient's medical chart review. Maternal morbidity will be assessed in terms of incidence of post-procedure rupture of membranes. Amniotic fluid level and membrane status will also be monitored at weekly intervals by ultrasonography.

  9. Maternal Outcomes- Maternal Morbidity- oligohydramnios [ Time Frame: Up to 6 weeks postpartum ]
    Case report forms are utilized to record study related data through patient's medical chart review. Maternal morbidity will be assessed in terms of incidence of post-procedure oligohydramnios.Amniotic fluid level and membrane status will also be monitored at weekly intervals by ultrasonography.

  10. Maternal Outcomes- Maternal Morbidity- chorioamnionitis [ Time Frame: Up to 6 weeks postpartum ]
    Case report forms are utilized to record study related data through patient's medical chart review. Maternal morbidity will be assessed in terms of incidence of post-procedure chorioamnionitis.

  11. Neonatal/Child outcomes- Pulmonary Morbidity - ECMO [ Time Frame: Up to 2 years of age ]
    Case report forms are utilized to record study related data through patient's medical chart. Short-term measures of neonatal pulmonary morbidity, including the need for extracorporeal membrane oxygenation.

  12. Neonatal/Child outcomes- Pulmonary Morbidity- ventilatory support [ Time Frame: Up to 2 years of age ]
    Case report forms are utilized to record study related data through patient's medical chart. Short-term measures of neonatal pulmonary morbidity, including the duration of neonatal ventilatory support.

  13. Neonatal/Child outcomes- Pulmonary Morbidity- Supplemental oxygen [ Time Frame: Up to 2 years of age ]
    Case report forms are utilized to record study related data through patient's medical chart. Short-term measures of neonatal pulmonary morbidity, including the need for administration of supplemental oxygen.

  14. Neonatal/Child outcomes- gastrointestinal morbidity [ Time Frame: Up to 2 years of age ]
    Case report forms are utilized to record study related data through patient's medical chart. Short-term measures of gastrointestinal morbidity.

  15. Neonatal/Child outcomes-neurologic morbidity [ Time Frame: Up to 2 years of age ]
    Case report forms are utilized to record study related data through patient's medical chart. Short-term measures of neurologic morbidity.

  16. Neonatal/Child outcomes- Survival to discharge from the hospital [ Time Frame: Up to 2 years of age ]
    Case report forms are utilized to record study related data through patient's medical chart. Survival to discharge from the hospital.

  17. Neonatal/Child outcomes- Duration of hospitalization. [ Time Frame: Up to 2 years of age ]
    Case report forms are utilized to record study related data through patient's medical chart. Duration of hospitalization after delivery.

  18. Neonatal/Child outcomes- need for supplemental oxygen [ Time Frame: Up to 18 years of age ]
    Case report forms are utilized to record study related data through patient's medical chart. Assessments of measures of long-term morbidity as the need for supplemental oxygen.

  19. Neonatal/Child outcomes- recurrent infection [ Time Frame: Up to 18 years of age ]
    Case report forms are utilized to record study related data through patient's medical chart. Assessments of measures of long-term morbidity as the rates of recurrent infection.

  20. Neonatal/Child outcomes- repeated hospitalization [ Time Frame: Up to 18 years of age ]
    Case report forms are utilized to record study related data through patient's medical chart. Assessments measures of long-term morbidity as the need for repeated hospitalization. A general health questionnaire will also be given in the form of an interview, either face to face or over the phone. The questionnaire contains questions regarding the children's health status; including hospitalizations, medications, surgical procedures, medical interventions and additional therapies he/she is receiving, and questions to evaluate his/her behavioral and social development.

  21. Neonatal/Child outcomes- Neurodevelopmental [ Time Frame: Up to 18 years of age ]
    DP-3 questionnaire will be utilized to record study related data. Assessments of neurodevelopmental outcomes.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  • Patient is a pregnant woman between 18 and 45 years of age
  • Singleton pregnancy
  • Confirmed diagnosis of severe or extremely severe left, right or bilateral CDH of the fetus

Severe CDH: -Fetal liver herniated into the left hemithorax -Lung-head ratio (LHR) is less than or equal to 1.0 calculated between 27+0/7 and 29+6/7 weeks' gestation

Extremely Severe CDH: -At least 1/3rd of the liver parenchyma herniated into the thoracic cavity -Lung-head ratio (LHR) is < 0.71 calculated between 22+0/7 and 29+6/7 weeks' gestation

  • Normal fetal echocardiogram or echocardiogram with a minor anomaly (such a small VSD) that in the opinion of the pediatric cardiologist will not affect postnatal outcome
  • Normal fetal karyotype
  • The mother must be healthy enough to have surgery
  • Patient provides signed informed consent that details the maternal and fetal risks involved with the procedure
  • Patient willing to remain in Houston for the duration following the balloon placement until delivery
  • Signed informed consent

EXCLUSION CRITERIA:

  • Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia
  • Allergy to latex
  • Allergy or previous adverse reaction to a study medication specified in this protocol
  • Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor)
  • Fetal aneuploidy, known structural genomic variants, other major fetal anomalies, or known syndromic mutation
  • Suspicion of major recognized syndrome (e.g. Fryns syndrome) on ultrasound or MRI
  • Maternal BMI >35
  • High risk for fetal hemophilia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00881660


Contacts
Contact: Michael Belfort, MD PhD 832 826-7375 belfort@bcm.edu
Contact: Wyoniquea D Rahming, MBA 832-826-7345 rahming@bcm.edu

Locations
United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Michael A. Belfort, MD PhD    832-826-7375    belfort@bcm.edu   
Contact: Carmen Luna Marcos de La Penha    832-826-7713    penha@bcm.edu   
Principal Investigator: Michael A. Belfort, MD PhD         
Sub-Investigator: Oluyinka Olutoye, MB, ChB, PhD         
Sub-Investigator: Olutoyin Olutoye, MB, ChB         
Sub-Investigator: Chistopher Cassady, MD         
Sub-Investigator: Jimmy Espinoza, MD         
Sub-Investigator: Magdalena Sanz Cortes, MD         
Sub-Investigator: Timothy Lee, MD         
Sub-Investigator: Alireza Abdollah Shamshirsaz, MD         
Sub-Investigator: Wesley Lee, MD         
Sub-Investigator: Sundeep Keswani, MD         
Sponsors and Collaborators
Michael Belfort
Baylor College of Medicine
Texas Children's Hospital
Investigators
Principal Investigator: Michael Belfort, MD, PhD Baylor College of Medicine/Texas Children's Hospital

Publications of Results:
Other Publications:

Responsible Party: Michael Belfort, Chairman and Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00881660     History of Changes
Other Study ID Numbers: H-28021
First Posted: April 15, 2009    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Michael Belfort, Baylor College of Medicine:
Fetal Tracheal Occlusion
congenital diaphragmatic hernia
FETO plug-unplug
Goldvalve balloon
Severe Congenital Diaphragmatic Hernia
Extremely Severe Congenital Diaphragmatic Hernia
Goldbal balloon
FETO

Additional relevant MeSH terms:
Hernia
Hernia, Diaphragmatic
Hernias, Diaphragmatic, Congenital
Pathological Conditions, Anatomical
Congenital Abnormalities