Fetoscopic Endoluminal Tracheal Occlusion in Severe Left Congenital Diaphragmatic Hernia
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 12/21/2018 |
| Start Date: | July 2015 |
| End Date: | June 2022 |
| Contact: | Holly L Hedrick, MD |
| Email: | hedrick@email.chop.ede |
| Phone: | 1-800-468-8376 |
Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)
CDH is a birth defect characterized by the development, very early in gestation, 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 abdomen can move into the chest and press on the
developing lungs. This prevents the lungs from growing and developing normally.
In severe cases, CDH can lead to serious disease and death at birth. For these babies,
treatment before birth may allow the lungs to grow enough before birth so these children are
capable of surviving and thriving.
the diaphragm, the breathing muscle that separates the chest from the abdomen. As a result,
the intestines and other organs in the abdomen can move into the chest and press on the
developing lungs. This prevents the lungs from growing and developing normally.
In severe cases, CDH can lead to serious disease and death at birth. For these babies,
treatment before birth may allow the lungs to grow enough before birth so these children are
capable of surviving and thriving.
Study Summary
All patients will complete a standard prenatal evaluation at the Center for Fetal Diagnosis
and Treatment (CFDT) to find out if they are candidates. The standard clinical assessments
include: Medical history and Physical exam, Level II ultrasound, Fetal echocardiogram, Fetal
magnetic resonance imaging (MRI), and a Psychosocial assessment.
If determined eligible, patients will be extensively counseled by the CFDT Team and those who
choose to participate will provide written, informed consent for study enrollment.
Up to 10 women will be enrolled in the FETO study. The mother and her unborn baby will
undergo two procedures. A balloon will be placed in the unborn baby's airway between 27+0/7 -
31 + 6/7 gestational age. The balloon blocks the airway and remains in place until balloon
removal. The timing for balloon removal will be determined by the CFDT Management Team and
can occur between 34 +0/7 - 34+6/7 gestational age.
Mothers enrolled in this study must remain near the fetal center, under close supervision,
from the time of balloon placement through delivery in the Garbose Family Special Delivery
Unit.
Weekly prenatal monitoring will occur after the first procedure at the CFDT and planned
delivery will occur in the Garbose Family Special Delivery Unit at term.
Postnatal stabilization and subsequent surgery to repair the diaphragm will take place at
CHOP.
Infants will be followed at CHOP at 6 months, 12 months, and 2 years of age and then
long-term in the Pulmonary Hypoplasia Program study at The Children's Hospital of
Philadelphia.
All patients will complete a standard prenatal evaluation at the Center for Fetal Diagnosis
and Treatment (CFDT) to find out if they are candidates. The standard clinical assessments
include: Medical history and Physical exam, Level II ultrasound, Fetal echocardiogram, Fetal
magnetic resonance imaging (MRI), and a Psychosocial assessment.
If determined eligible, patients will be extensively counseled by the CFDT Team and those who
choose to participate will provide written, informed consent for study enrollment.
Up to 10 women will be enrolled in the FETO study. The mother and her unborn baby will
undergo two procedures. A balloon will be placed in the unborn baby's airway between 27+0/7 -
31 + 6/7 gestational age. The balloon blocks the airway and remains in place until balloon
removal. The timing for balloon removal will be determined by the CFDT Management Team and
can occur between 34 +0/7 - 34+6/7 gestational age.
Mothers enrolled in this study must remain near the fetal center, under close supervision,
from the time of balloon placement through delivery in the Garbose Family Special Delivery
Unit.
Weekly prenatal monitoring will occur after the first procedure at the CFDT and planned
delivery will occur in the Garbose Family Special Delivery Unit at term.
Postnatal stabilization and subsequent surgery to repair the diaphragm will take place at
CHOP.
Infants will be followed at CHOP at 6 months, 12 months, and 2 years of age and then
long-term in the Pulmonary Hypoplasia Program study at The Children's Hospital of
Philadelphia.
Inclusion Criteria:
1. Pregnant women age 18 years and older, who are able to consent
2. Singleton pregnancy
Fetal:
3. Normal Karyotype
4. Diagnosis of Isolated Left CDH with liver up
5. Gestation at enrollment prior to 29 weeks plus 5 days
6. SEVERE pulmonary hypoplasia with Ultrasound Observed/Expected Lung-to-Head Ratio (O/E
LHR) < 30%
Exclusion Criteria:
1. Pregnant women < 18 years
2. Maternal contraindication to fetoscopic surgery or severe maternal medical condition
in pregnancy
3. Technical limitations precluding fetoscopic surgery
4. Rubber latex allergy
5. 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
6. Psychosocial ineligibility, precluding consent
7. Fetal Diaphragmatic hernia: right-sided or bilateral, major associated anomalies,
isolated left-sided with the O/E LHR ≥ 30%
8. Inability to remain at FETO site during time period of tracheal occlusion, delivery
and postnatal care
9. Declining concurrent enrollment in Pulmonary Hypoplasia Program study for long term
follow up.
We found this trial at
1
site
South 34th Street
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
215-590-1000
Phone: 800-468-8376
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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