Pilot Trial FETO for CDH
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-008720
NCT ID: NCT03138863
Sponsor Protocol Number: 16-008720
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Donald Potter, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available