Actively Recruiting
North American Fetal Therapy Network for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
Led by The University of Texas Health Science Center, Houston · Updated on 2025-08-19
80
Participants Needed
1
Research Sites
351 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate successful placement and removal of Fetoscopic Endoluminal Tracheal Occlusion (FETO) device in cases of intrathoracic liver herniation with isolated left congenital diaphragmatic hernia (LCDH) with Observed/Expected (O/E) Lung to Head Circumference Ratio (LHR) \< 30% or isolated right congenital diaphragmatic hernia (RCDH) with O/E LHR \< 45%,to 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 weeks 0 days to 29weeks 6 days of gestation to those with intrathoracic liver herniation, isolated LCDH and o/e LRH \< 30% that undergo expectant management, to compare the neonatal survival rate to discharge from the neonatal intensive care units (NICU), between fetuses with intrathoracic liver herniation, isolated RCHD with o/e LHR \< 45% that undergo FETO procedure performed at 27 weeks 0 days to 29 weeks 6 days gestation to those with intrathoracic liver herniation, isolated RCHD and o/e LHR \< 45% that elect to proceed with expectant management, to evaluate the frequency of maternal and fetal complications associated with FETO procedure, to evaluate whether the FETO procedure is associated with reduced long-term mortality and morbidities in isolated LCDH survivors with o/e LHR \<30% when compared to isolated LCDH with o/e LRH \<30% that undergo expectant management where all fetuses were found to have intrathoracic liver herniation and to evaluate whether the FETO procedure is associated with reduced long-term mortality and morbidities in isolated RCDH survivors with o/e LHR ≤ 45% when compared to isolated RCHD with LHR \< 45% that undergo expectant management where all fetuses were found to have intrathoracic liver herniation
CONDITIONS
Official Title
North American Fetal Therapy Network for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women able to give consent
- Singleton pregnancy
- Normal genetic testing results (Karyotype, chromosomal microanalysis, whole exome or genome sequencing)
- Gestational age less than 29 weeks 6 days at enrollment
- Intrathoracic liver herniation present
- Isolated left CDH with O/E LHR less than 30% or isolated right CDH with O/E LHR less than 45% at enrollment
- Cervical length greater than 20 mm by ultrasound within 24 hours before FETO procedure
- Meets psychosocial criteria
- Informed consent understood
You will not qualify if you...
- History of natural rubber latex allergy
- Preterm labor, shortened cervix (less than 20 mm) or uterine anomaly that increases preterm labor risk
- Placenta previa
- Psychosocial factors preventing consent or support during pregnancy
- Bilateral CDH or isolated left CDH with O/E LHR 30% or higher, or isolated right CDH with O/E LHR higher than 45%
- No liver herniation into the chest
- Additional fetal anomalies or chromosomal abnormalities affecting survival
- Maternal health issues preventing fetoscopic surgery
- History of incompetent cervix with or without cerclage
- Known placental abnormalities (previa, abruption, accreta)
- Maternal-fetal Rh incompatibility or neonatal immune thrombocytopenia
- Positive maternal HIV, Hepatitis B or C status
- Uterine abnormalities such as large or multiple fibroids
- No safe or feasible approach for balloon placement
- Participation in other intervention studies affecting maternal or fetal health, or prior participation in this trial during a previous pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Anthony Johnson, DO
CONTACT
E
Elisa Garcia
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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