Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO)

Congenital Diaphragmatic Hernias Clinical Trial

Official title:

Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06064188
• Other study ID #: 22-133 FETO
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: September 2023
• Source: Connecticut Children's Medical Center
• Contact: Timothy Crombleholme, MD
• Phone: 860-545-9830
• Email: tcrombleholme[@]connecticutchildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore adequate lung growth for neonatal survival.

Description:

Prenatal tracheal occlusion (TO) obstructs the normal egress of lung fluid during pulmonary development leading to increased lung tissue stretch, increased cell proliferation, and accelerated lung growth. European colleagues have developed foregut endoscopy and techniques to position and remove endoluminal tracheal balloons in utero. Recently, the Belgium group published summary results of FETO showing an improved survival in 175 patients with isolated left CDH from 24% to 49%.

The goal of this pilot study is to study the feasibility of implementing FETO therapy in the most severe group of fetuses with left CDH Observed/expected lung-to-head ratio < 25%(O/E LHR < 25%).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant women age 18 years and older, who are able to consent

• Singleton pregnancy

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Fetoscopic Endoluminal Tracheal Occlusion (FETO)
This study will position and remove an endoluminal tracheal balloon in utero (FETO) to study the feasibility of implementing FETO therapy in the most severe group of fetuses with left CDH and observed/expected length head ratio <25% (O/E LHR).

Locations

Country	Name	City	State
United States	Connecticut Children's Medical Center	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Timothy Crombleholme

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of neonatal survivors at time of discharge	Percent of neonatal survivors at time of discharge	Discharge from the hospital, an expected average of 12 weeks.
Secondary	Prenatal increase in lung volume	Lung volume after FETO procedure	2 weeks (prenatally)
Secondary	Number of days of Postnatal mechanical ventilator support	mechanical ventilator support will be monitored and recorded in days of use	First 28 days of postnatal life