Trial record 1 of 18 for:    "Congenital diaphragmatic hernia"
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Fetal Endotracheal Occlusion (FETO) in Severe Congenital Diaphragmatic Hernia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Baylor College of Medicine
Texas Children's Hospital
Information provided by (Responsible Party):
Michael Belfort, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00881660
First received: April 13, 2009
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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 15 FETO procedures on fetuses diagnosed prenatally with severe and extremely severe CDH.


Condition Intervention
Congenital Diaphragmatic Hernia
Device: Goldvalve Detachable Balloon

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Prospective Study of the Effectiveness of Fetal Endotracheal Occlusion (FETO) in the Management of Severe Congenital Diaphragmatic Hernia

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Feasibility [ Time Frame: Study Duration ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: March 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fetal Endotracheal Occlusion
Placement of the Goldvalve tracheal balloon using the plug/unplug method.
Device: Goldvalve Detachable Balloon
Between 22+0/7 - 29+ 6/7 weeks gestation, placement of the Goldvalve detachable balloon. At 34 weeks gestation (or a maximum of 10 weeks if placed prior to 24 weeks gestational age), removal of the balloon.

Detailed Description:

Enrollment

Women carrying fetuses with left-sided severe or extremely severe CDH and a normal karyotype will undergo evaluation. The fetuses will be 27+0/7 to 29+6/7 weeks of gestational age for severe CDH and can be as early at 22+0/7 for those deemed as "extremely severe" cases of CDH. They will have ultrasound and/or MRI evaluation to rule out other anomalies, calculation of the LHR from ultrasound measurements, echocardiography, and detailed obstetric/perinatal consultation. Patients who meet the eligibility criteria will be extensively counseled, and those who wish to participate will provide written, informed consent for the study.

Procedure

The procedure will be performed under spinal anesthesia or local anesthesia with intravenous sedation. The technique of fetal endoscopic tracheal occlusion has been described. Using standard technique, a cannula loaded with a pyramidal trocar will be inserted into the amniotic cavity and a fetoscope or flexible operating endoscope will be passed through the cannula into the amniotic fluid. The scope will be guided into the fetal larynx either through a nostril and then via the nasal passage or through the fetal mouth, and then through the fetal vocal cords with the aid of both direct vision through the scope and cross-sectional ultrasonographic visualization. A detachable latex balloon will be placed in the fetal trachea midway between the carina and the vocal cords. The balloon will be inflated with isosmotic contrast material so that it fills the fetal trachea.

Postoperative

The mothers will be discharged once stable. Serial measurements of sonographic lung volume and LHR will begin within 24-48 hours following surgery and continue weekly by targeted ultrasound evaluation. Amniotic fluid level and membrane status will also be monitored at weekly intervals. Comprehensive ultrasonography for fetal growth will be performed every four weeks. All discharged patients will stay within 30 minutes of TCH to permit standardized postoperative management and emergent retrieval of the balloon in the event of preterm labor or premature rupture of membranes prior to the scheduled removal.

Balloon retrieval will be planned at between 32+0/7 and 34+6/7 weeks at the discretion of the FETO center. The patient will need to commit to remaining in 30 minutes of Texas Children's Hospital Pavilion for Women until the balloon is retrieved.

After removal of the balloon, patients will have the choice of delivering at Texas Children's Hospital- Women's Pavilion with the CDH managed and repaired at TCH, or returning to their obstetrician for delivery with subsequent repair of the CDH by the pediatric surgeons at their referring facility. Given the severity of the CDH, the baby will need to be delivered in a facility that has the capability of immediate pediatric surgery services.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  • Patient is a pregnant woman between 18 and 45 years of age
  • Fetus is between 22+0/7 and 29+6/7 weeks of gestation at time of surgery
  • Singleton pregnancy
  • Confirmed diagnosis of severe or extremely severe CDH of the fetus

Severe CDH:

  • Fetal liver herniated into the left hemithorax
  • Lung-head ratio (LHR) is ≥ 0.71 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 week's gestation

    • Patient is able to give informed consent
    • 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
    • No evidence of other major fetal anomalies on ultrasound (e.g. Frynn's syndrome) or MRI
    • The mother must be healthy enough to have surgery and she must fully understand and accept the maternal and fetal risks involved
    • Patient is willing to remain in Houston, TX throughout the duration of balloon placement

EXCLUSION CRITERIA:

  • Failure to meet all inclusion criteria
  • Allergy to latex
  • Known allergy or previous adverse reaction to a study medication specified in this protocol
  • Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia
  • Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor)
  • Fetal aneuploidy, known structural genomic variants, or known syndromic mutation
  • Suspicion of major recognized syndrome (e.g. Frynn's syndrome)
  • BMI > 35
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881660

Locations
United States, Texas
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, United States, 77030
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
  More Information

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
Study First Received: April 13, 2009
Last Updated: January 22, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Hernia
Hernia, Diaphragmatic
Hernia, Hiatal
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 23, 2014