View Clinical Trial (Medical Research Study)
The Effectiveness of Fetal Endotracheal Occlusion (FETO) in the Management of Severe Congenital Diaphragmatic Hernia
| City: |
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Houston |
| State: |
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Texas |
| Zip Code: |
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77030 |
| Conditions: |
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Congenital Diaphragmatic Hernia |
| Purpose: |
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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 CDH.
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| Study Summary: |
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Enrollment
Women carrying fetuses with left-sided CDH and a normal karyotype will undergo evaluation.
The fetuses will be 22+0/7 to 29+6/7 weeks of gestational age. 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.
After removal of the balloon, patients will have the choice of delivering at Texas
Children's Hospital Pavilion for Women 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.
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| Criteria: |
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Inclusion Criteria:
- Patient is a pregnant woman between 18 and 45 years of age
- Patient is able to give informed consent
- Normal fetal echocardiogram
- Normal fetal karyotype
- No evidence of other major fetal anomalies on ultrasound or MRI
- Confirmed diagnosis of CDH of the fetus
- Fetal liver herniated into the left hemithorax
- LHR is 1.0 or less, calculated between 22+0/7 weeks and 29+6/7 weeks of gestation
- Fetus is between 22+0/7 and 29+6/7 weeks of gestation at time of surgery
- Singleton pregnancy
- 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 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
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| NCT ID: |
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NCT00881660 |
| Primary Contact: |
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Principal Investigator
Michael Belfort, MD, PhD
Baylor College of Medicine/Texas Children's Hospital
Michael Belfort, MD PhD
Phone: 832 826-7375
Email: belfort@bcm.edu
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| Backup Contact: |
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Email: kkchappe@bcm.edu
Kara Chappell, MPH
Phone: 832 824-0401
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| Location Contact: |
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Houston, Texas 77030
United States
Michael A. Belfort, MD PhD
Phone: 832-826-7375
Email: belfort@bcm.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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