Fetal Endotracheal Occlusion (FETO) in the Resolution of Pulmonary Hypertension in Fetuses With Severe CDH

Launched by MICHAEL A BELFORT · Jun 7, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a procedure called fetal tracheal occlusion (FETO) to see if it can help improve lung development and reduce complications in unborn babies with severe congenital diaphragmatic hernia (CDH). CDH is a condition where a hole in the diaphragm allows organs from the abdomen to move into the chest, which can hinder lung growth and lead to serious health issues after birth. The researchers want to find out if performing FETO can not only help the lungs develop better but also lower the chances of pulmonary hypertension (high blood pressure in the lungs) in these infants by the time they reach 1 year old.

To participate in this trial, pregnant women aged 18 to 45 who are carrying a single baby with a confirmed diagnosis of severe left or right-sided CDH may be eligible. Key criteria include being between 28 and 31 weeks pregnant and having a healthy mother and fetus. Women who join the study will undergo the FETO procedure and will be monitored closely. The trial aims to gather information from about 40 participants who will have the procedure and compare their outcomes to a similar group of babies with CDH who won’t have the FETO procedure for various reasons. It’s an important study that could provide valuable insights into improving care for these vulnerable infants.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Patient is a pregnant woman between 18 and 45 years of age
• • Singleton pregnancy
• • The fetuses will be 28+0/7 to 31+6/7 weeks of gestational age
• • Confirmed diagnosis of severe left- or right-sided CDH of the fetus: Observed/expected total lung volume equal to or less than 0.32 with more than 21% of liver herniated into the hemithorax. (Ideally calculated between 28+0/7 and 31+6/7 weeks' gestation.)
• • Normal fetal echocardiogram or echocardiogram with a minor anomaly (such a small VSD) that in the opinion of the pediatric cardiologist will not affect postnatal outcome
• • Normal fetal karyotype or microarray
• • The mother must be healthy enough to have surgery
• • Patient and father of the baby provide signed informed consent that details the maternal and fetal risks involved with the procedure
• • Patient willing to remain in Houston for the duration following balloon placement until delivery.
• Exclusion Criteria:
• • Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia
• • Allergy to latex
• • Allergy or previous adverse reaction to a study medication specified in this protocol
• • Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) in the index pregnancy.
• • Fetal aneuploidy, known structural genomic variants, other major fetal anomalies that may impact the fetal/neonatal survival or known syndromic mutation
• • Suspicion of major recognized syndrome (e.g. Fryns syndrome) on ultrasound or MRI
• • Maternal BMI \>40
• • High risk for fetal hemophilia