Feto-Endoscopic Tracheal Occlusion (FETO) for Left Congenital Diaphragmatic Hernia

Congenital Diaphragmatic Hernia Clinical Trial

— FETO  

Official title:

Feto-Endoscopic Tracheal Occlusion (FETO) for Left Congenital Diaphragmatic Hernia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02986087
• Other study ID #: 2015-6413
• Status: Recruiting
• Phase: N/A
• Start date: November 2016
• Est. completion date: December 2026

Study information

• Verified date: July 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Foong-Yen Lim, MD
• Phone: (513) 636-6259
• Email: Foong-Yen.Lim[@]cchmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses.

Description:

Fetuses with congenital diaphragmatic hernia with liver-up, and an observed to expected lung-to-head ratio of <25%, LHR <1, or a moderate category with o/e LHR <30%, singleton pregnancy, no known other anomalies, gestational age < 29 weeks 6 days (severe), gestational age < 31 weeks 6 days (moderate), no maternal disease, maternal age > 18 years old…. meet criteria to be offered fetal tracheal occlusion. We want to test feasibility and efficacy in our center.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Isolated CDH with liver up
• Severe pulmonary hypoplasia with ultrasound O/E LHR <25% at the time of surgery
• Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days
• Moderate pulmonary hypoplasia with ultrasound O/E LHR <30% and liver-up at the time of surgery
• Gestational age at FETO procedure 30 weeks 0 days to 31 weeks 6 days in this moderate category
• Maternal age greater than or equal to 18 years
• Gestational age at enrollment prior to 29 weeks 6 days, or 31 weeks 6 days in moderate category
• Normal karyotype or FISH
• Normal fetal echocardiogram
• Singleton pregnancy
• Willing to remain in the greater Cincinnati area for remainder of pregnancy
• Family considered and decline option of termination of the pregnancy at less than 24 weeks 0 days
• Family meets psychosocial criteria

Exclusion Criteria:

• Patient < 18 years old
• Multi-fetal pregnancy
• Rubber latex allergy
• Preterm labor, cervix shortened (<15 mm) or uterine anomaly strongly predisposing to preterm labor, placenta previa
• Bilateral CDH, isolated left sided CDH with an O/E > 30%
• Additional fetal anomaly by ultrasound, MRI, or echocardiogram
• Chromosomal abnormalities
• Maternal contraindications to fetoscopic surgery or severe maternal condition in pregnancy
• Incompetent cervix with or without a cerclage
• Placental abnormalities known at time of enrollment
• Maternal HIV, Hepatits B, Hepatitis C
• Maternal uterine anomaly
• No safe or technically feasible fetoscopic approach to balloon placement
• Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy

Related Conditions & MeSH terms

• Congenital Diaphragmatic Hernia
• Hernia
• Hernia, Diaphragmatic
• Hernias, Diaphragmatic, Congenital
• Hypertension, Pulmonary
• Pulmonary Hypoplasia
• Pulmonary; Hypertension

Intervention

Device:
• Fetal Tracheal Occlusion
Fetuses with congenital diaphragmatic hernia with an observed to expected lung-to-head ratio of <25%, LHR <1, o/e LHR<30% (moderate), singleton pregnancy, no known other anomalies, gestational age < 29 weeks 6 days, no maternal disease, maternal age > 18 years old meet criteria to be offered tracheal occlusion. We want to test feasibility and efficacy in our center as a requirement to enter the TOTAL trial.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center (CCHMC)	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change lung growth on prenatal imaging	Change in o/eLHR and other prenatal imaging tests	prenatal period up to 40 weeks gestation
Secondary	Change survival in the severe congenital diaphragmatic hernia subgroup	Change rate of survival	6 months
Secondary	Change need for ECMO therapy	Change need for ECMO therapy	6 months
Secondary	Change pulmonary hypertension	Change pulmonary hypertension	6 months
Secondary	Change neonatal morbidity	Change neonatal morbidity	1 year