Fetoscopic Endoluminal Tracheal Occlusion in Severe Left Congenital Diaphragmatic Hernia

Launched by CHILDREN'S HOSPITAL OF PHILADELPHIA · Sep 11, 2015

Keywords

ClinConnect Summary

This clinical trial is studying a treatment for babies who have a serious condition called Congenital Diaphragmatic Hernia (CDH), which occurs when a hole in the diaphragm allows organs to move into the chest and can prevent the lungs from developing properly. The goal of the trial is to see if a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) can help these babies by blocking the trachea (the tube that carries air to the lungs) to allow more lung growth before birth. This could give them a better chance of surviving and thriving after they are born.

To participate in this trial, pregnant women must be at least 18 years old and have a single baby diagnosed with isolated left CDH. They should be enrolled before 29 weeks of pregnancy and have a severe form of lung underdevelopment. Participants will undergo a special procedure and will be monitored closely throughout the process. It’s important to note that this trial is actively looking for participants, and there are specific health criteria that must be met to ensure safety for both the mother and baby. If you think you might qualify or want to learn more, discussing it with your healthcare provider could be a great next step.

Gender

FEMALE

Eligibility criteria

• 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