Status:
COMPLETED
Fetal Endotracheal Occlusion (FETO) in Severe and Extremely Severe Congenital Diaphragmatic Hernia
Lead Sponsor:
Michael A Belfort
Collaborating Sponsors:
Baylor College of Medicine
Conditions:
Congenital Diaphragmatic Hernia
Eligibility:
FEMALE
18-45 years
Phase:
NA
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 ab...
Detailed Description
Enrollment Women carrying fetuses with severe or extremely severe CDH and a normal karyotype will undergo routine clinical evaluation. The fetuses will be 27+0/7 to 29+6/7 weeks of gestational age fo...
Eligibility Criteria
Inclusion
- 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 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 \>40
- High risk for fetal hemophilia
Exclusion
Key Trial Info
Start Date :
February 21 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00881660
Start Date
February 21 2012
End Date
April 11 2023
Last Update
November 14 2025
Active Locations (1)
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1
Texas Children's Hospital
Houston, Texas, United States, 77030