Pilot Trial: FETO for Congenital Diaphragmatic Hernia (CDH)
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 5/20/2018 |
| Start Date: | May 8, 2017 |
| End Date: | December 31, 2019 |
| Contact: | Maureen A Lemens, R.N. |
| Email: | Lemens.Maureen@mayo.edu |
| Phone: | 507-293-1487 |
Pilot Trial of Fetal Endoscopic Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH) at Mayo Clinic
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.
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.
Inclusion Criteria:
- 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 prior to 29 wks plus 6 days
- SEVERE pulmonary hypoplasia with US O/E lung area to head circumference ratio (LHR) <
25% (measured at 180 to 296 weeks) at the time of surgery; O/E LHR 25% to <30%
(measured at 300 to 316 weeks) at time of surgery.
- Gestational age at FETO procedure with O/E LHR <25% at 27 weeks 0 days to 29 weeks 6
days; with O/E LHR 25% to <30% at 30 weeks 0 days to 31 weeks 6 days as determined by
clinical information (LMP) and evaluation of first ultrasound
- Patient meets psychosocial criteria
Exclusion Criteria:
- Multi-fetal pregnancy
- 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:
- Inability to reside within 30 minute drive of Mayo Clinic, and inability to
comply with the travel for the follow-up requirements of the trial
- Patient does not have a support person (e.g. spouse, partner, mother) available
to stay with the patient for the duration of the pregnancy at Mayo Clinic.
- Right sided CDH or bilateral CDH, isolated left sided with O/E LHR ≥30% (measured at
180 to 295 weeks) as determined by ultrasound
- Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or
echocardiogram at the fetal treatment center. No cases will be removed post hoc if
abnormalities are discovered in the course of post-operative monitoring
- Maternal contraindication to fetoscopic surgery or severe maternal medical condition
in pregnancy
- History of incompetent cervix with or without cerclage
- Placental abnormalities (previa, abruption, accrete) known at time of enrollment
- Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune
thrombocytopenia affecting the current pregnancy
- Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk
of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or
Hepatitis status is unknown, the patient must be tested and found to have negative
results before enrollment
- Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality
- There is no safe or technically feasible fetoscopic approach to balloon placement
- Participation in another intervention study that influences maternal and fetal
morbidity and mortality or participation in this trial in a previous pregnancy
We found this trial at
1
site
Rochester, Minnesota 55905
Principal Investigator: Rodrigo Ruano, M.D.
Phone: 507-293-1487
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