Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)

Diaphragmatic Hernia Clinical Trial

Official title: Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)

Status Not yet recruiting

Clinical Trial Summary

This is a single site, single arm, non-randomized, pilot trial to assess the feasibility and safety of treating severe congenital diaphragmatic hernia (CDH) with Fetal Endoscopic Tracheal Occlusion (FETO) at Columbia University Irving Medical Center (CUIMC)/ NewYork-Presbyterian Hospital (NYP).

Clinical Trial Description

Congenital diaphragmatic hernia (CDH) affects 1 in 2,200 to 5,000 live births per year. The defect in the fetal diaphragm allows abdominal organs (intestine, stomach, liver, spleen) to migrate into the thorax, hindering normal lung development. The herniated contents place pressure on the developing lungs and this may result in varying degrees of pulmonary hypoplasia and associated pulmonary hypertension; both of which may be lethal. In an attempt to prenatally quantify the impact of the herniated organs on underlying lung development, prognostic tools have been developed. The most widely used prognostic indicator is lung-to-head ratio (LHR) as measured by prenatal ultrasound. The lung contralateral to the diaphragmatic defect is measured in a transverse plane at the level of the four chamber heart and its area is divided by the fetal head circumference (LHR). The LHR is tracked through the pregnancy but seems to be most strongly correlated with outcomes in the early third trimester.

Fetuses with severe CDH have a high risk of mortality. The current standard of care treatment offers postnatal repair, which is associated with overall survival of 71% in all cases. A majority (68%) of fetuses are prenatally diagnosed, and the survival in this cohort is even lower at 65%. The severity of the defect can be measured prenatally by the degree of pulmonary hypoplasia, and the survival drops to below 30% for those with expected lung volumes below 30% of expected. The purpose of the FETO procedure in severe CDH patients is to improve prenatal lung growth in order to potentially increase neonatal survival. ;

Related Conditions & MeSH terms

• Diaphragmatic Hernia
• Hernia
• Hernia, Diaphragmatic
• Hernias, Diaphragmatic, Congenital

• NCT number: NCT05354505
• Study type: Interventional
• Source: Columbia University
• Contact: Amanda Alonso, MHA
• Phone: 212-342-0261
• Email: aa2974@cumc.columbia.edu
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2023
• Completion date: June 2027