Fetoscopic Endoluminal Tracheal Occlusion in Severe Left Congenital Diaphragmatic Hernia (CHOP_FETO)

Children's Hospital of Philadelphia (CHOP)

Status: Active, not recruiting

Conditions: Pulmonary Hypoplasia; Congenital Diaphragmatic Hernia

Treatments: Device: GoldBAL2 Detachable Balloon and BALTACCIBDPE100 Delivery Catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT02549820

15-011714

Details and patient eligibility

About

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.

Full description

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 25 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 - 29+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 at The Children's Hospital of Philadelphia.

Enrollment: 14 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Pregnant women age 18 years and older, who are able to consent

2. Singleton pregnancy

   Fetal:

3. Normal Karyotype or chromosomal microarray with non-pathologic variants

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) < 25%

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 ≥ 25%
8. Inability to remain at FETO site during time period of tracheal occlusion, delivery and postnatal care

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

FETO in CDH

Experimental group

Description:

Fetoscopic Endoluminal Tracheal Occlusion (FETO) will be performed by placing a detachable balloon inside the fetal airway and removing the balloon after several weeks. Devices: GoldBAL2 Detachable Balloon and BALTACCIBDPE100 Delivery Catheter

Treatment:

Device: GoldBAL2 Detachable Balloon and BALTACCIBDPE100 Delivery Catheter