An interventional study of FETO with GoldBAL2 Balloon and BALTACCIBDPE100 Catheter in Congenital Diaphragmatic Hernia and Pulmonary Hypoplasia, sponsored by Holly L Hedrick, MD. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Holly L Hedrick, MD · Not applicable, Interventional, and Treatment
Congenital diaphragmatic hernia (CDH) is a birth defect characterized by the development of a hole in the diaphragm, the breathing muscle that separates the chest from the abdomen. As a result, 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.
All patients will complete a standard prenatal evaluation at the Children's Hospital of Philadelphia (CHOP) Center for Fetal Diagnosis and Treatment (CFDT) to determine if they are candidates for this study. 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 for fetoscopic endoluminal tracheal occlusion (FETO) intervention, 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 40 maternal/fetal dyads will be enrolled in the intervention arm of this study. The pregnant patient and fetus will undergo two procedures. A balloon will be placed in the fetal 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.
Pregnant patients enrolled in the intervention arm of study must remain near the fetal center, under close supervision, from the time of balloon placement through delivery in the CHOP 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.
Up to 40 maternal/fetal dyads which meet criteria according to defect side, observed/expected lung to head ratio (O/E LHR), and liver position, but undergo expectant management rather than FETO intervention, will be enrolled in the control arm of this study.
Infants in both the intervention arm and the control arm will be followed at CHOP at 6 months, 12 months, 18 months, and 24 months of age through the CHOP Pulmonary Hypoplasia Program.
Exclusion Criteria:
Psychosocial ineligibility, precluding consent:
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. Assignment will be non-randomized. 40 maternal/fetal dyads will be enrolled in this arm.
Device: FETO with GoldBAL2 Balloon and BALTACCIBDPE100 Catheter
The control arm includes patients eligible for FETO according to side of defect, O/E LHR, and liver position who undergo expectant management rather than FETO intervention. Assignment will be non-randomized. 40 maternal/fetal dyads will be enrolled in this arm.
Fetoscopic Endoluminal Tracheal Occlusion (FETO) in CDH with GoldBAL2 Detachable Balloon and BALTACCIBDPE100 Delivery Catheter
Successful placement and removal of the FETO Device
Evalutation of successful placement and removal of the fetoscopic endoluminal tracheal occlusion (FETO) device in cases of intrathoracic liver herniation with isolated left congenital diaphragmatic hernia (LCDH) with observed/expected lung to head ratio (O/E LHR) \< 30% or isolated right congenital diaphragmatic hernia (RCDH) with O/E LHR \< 45%.
Time frame: 24 months
Comparison of neonatal survival rates of LCDH cases between intervention and control groups
Compare survival to discharge from the neonatal intensive care units (NICU), between fetuses with intrathoracic liver herniation and isolated LCDH with O/E LHR \< 30% that receive FETO procedure performed at 27\^0 to 29\^6 weeks gestation to concurrent patients with intrathoracic liver herniation, isolated LCDH and O/E LRH \< 30% that undergo expectant management.
Time frame: 24 months
Comparison of neonatal survival rates of RCDH cases between intervention and control groups
Compare the neonatal survival rate to discharge from the neonatal intensive care units (NICU), between fetuses with intrathoracic liver herniation, isolated RCDH with O/E LHR \< 45% that undergo FETO procedure performed at 27\^0 to 29\^6 weeks gestation to concurrent patients with intrathoracic liver herniation, isolated RCDH and O/E LHR \< 45% that proceed with expectant management.
Time frame: 24 months
Assessment of complications associated with the FETO intervention
Evaluate the frequency of maternal and fetal complications associated with the FETO intervention.
Time frame: 24 months
Comparison of long-term mortality and morbidity of LCDH cases between intervention and control groups
Evaluate whether the FETO procedure is associated with reduced long-term mortality and morbidities at 6, 12, 18 and 24 months in isolated LCDH survivors with O/E LHR \< 30% when compared to concurrent isolated LCDH with O/E LRH \< 30% that undergo expectant management where all fetuses were found to have intrathoracic liver herniation.
Time frame: 24 months
Comparison of long-term mortality and morbidity of RCDH cases between intervention and control groups
Evaluate whether the FETO procedure is associated with reduced long-term mortality and morbidities at 6, 12, 18, and 24 months in isolated RCDH survivors with O/E LHR ≤ 45% when compared to concurrent isolated RCDH with LHR ≤ 45% that undergo expectant management where all fetuses were found to have intrathoracic liver herniation.
Time frame: 24 months
Plan to share: Yes — A deidentified data set will be shared with other NAFTNet institutions which perform FETO. These data will be shared under a data sharing agreement.
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Hernias, Diaphragmatic, Congenital→