Pilot Trial FETO for CDH

Overview

About this study

Subjects to be enrolled in this study are pregnant women whose unborn baby has been diagnosed with severe congenital diaphragmatic hernia (CDH). CDH is a birth defect occurring early in pregnancy. It is characterized by the development of a hole in the diaphragm, the breathing muscle that separates the chest from the abdomen. As a result, the intestines and other organs in the baby's abdomen can move into the chest and press on the developing lungs. CDH is a serious condition which prevents the fetal lungs from developing normally. The purpose of this study is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO). FETO involves two surgical procedures while the mother is still pregnant. During the early third trimester of pregnancy, a special tiny balloon is placed in the baby's trachea. After the balloon has been in place for several weeks, the balloon will be removed during a second procedure, generally done when the baby has reached about 34 weeks gestation. The intent of the FETO procedure is to improve development of the lungs in fetuses diagnosed with severe CDH. If better lung development can be promoted, it is expected that overall survival of babies with severe CDH after birth will also be improved.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Pregnant women age 18 years and older.
  • Singleton pregnancy.
  • Normal fetal karyotype with confirmation by culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks.
  • Isolated Left CDH with liver up.
  • Gestation age at enrollment is less than or equal to 31 weeks plus 6 days as determined by clinical information (LMP) and evaluation of firstultrasound. 
  • In this study we will classify potential participants as either Extremely Severe CDH; Severe CDH; or CDH based on the O/E LHR:
    • Extremely Severe CDH is defined as O/E LHR of <20%measured at 180 to 296 weeks;
    • Severe CDH is defined as O/E LHR of 20% to <25% (measured at 180 to 296 weeks);
    • CDH for the purposes of this study is defined as O/E LHR of 25% to <30% (measured at 180 to 316 weeks).
  • Gestational age at FETO procedure will be:
    • at 22 weeks 0 days to 29 weeks 6 days for fetuses with O/E LHR <20%;
    • at 27 weeks 0 days to 29 weeks 6 days for fetuses with O/E LHR <25%;
    • at 30 weeks 0 days to 31 weeks 6 days for fetuses with O/E LHR between 25% and <30%.
  • Patient meets psychosocial criteria.
  • Informed consent.

Exclusion Criteria:

  • Pregnant women < 18 years.
  • Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy.
  • Technical limitations precluding fetoscopic surgery.
  • History of natural rubber latex allergy .
  • Preterm labor, cervix shortened (<15 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa.
  • Psychosocial ineligibility, precluding consent.
  • Diaphragmatic hernia: right-sided or bilateral, major associated anomalies, isolated left-sided with the O/E LHR ≥ 30%.
  • Inability to remain at FETO site during time period of tracheal occlusion, delivery and postnatal care.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Rodrigo Ruano, M.D., Ph.D.

Open for enrollment

Contact information:

Maureen Lemens R.N.

(507) 293-1487

Lemens.Maureen@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20319146

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