Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH

Launched by CONNECTICUT CHILDREN'S MEDICAL CENTER · Aug 19, 2015

Keywords

ClinConnect Summary

This clinical trial is studying a special treatment called Fetoscopic Endoluminal Tracheal Occlusion (FETO) for babies who have a serious condition known as congenital diaphragmatic hernia (CDH). This condition affects the diaphragm, which is the muscle that helps us breathe, and can lead to underdeveloped lungs in the baby. The goal of this trial is to help improve lung growth before the baby is born, which can increase their chances of survival after delivery.

To participate in this trial, pregnant women must be 18 years or older and have a single baby (not twins). The baby must have a specific type of CDH on the left side, with certain ultrasound findings that show severe lung underdevelopment. The trial is currently looking for participants who are still early in their pregnancy, before 30 weeks. If you meet these criteria and are interested, you would receive the FETO procedure and then be closely monitored during pregnancy and after the baby is born. It's important to note that there are some health conditions and situations that could prevent participation, so it’s best to discuss any concerns with your doctor.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Pregnant women age 18 years and older, who are able to consent
• • Singleton pregnancy
• • Fetal
• • Normal Karyotype
• • Fetal Diagnosis of Isolated Left CDH with liver up
• • Gestation at enrollment prior to 29 wks plus 6 days
• • SEVERE pulmonary hypoplasia with Ultra Sound O/E LHR \< 25%
• Exclusion Criteria:
• • Pregnant women \<18 years of age.
• • Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
• • Technical limitations precluding fetoscopic surgery
• • 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
• • Diaphragmatic hernia: right-sided or bilateral, major associated anomalies, isolated left-sided with the O/E LHR ≥ 25%
• • Inability to remain at FETO site during time period of tracheal occlusion, delivery and postnatal care