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

Not Applicable

Recruiting

• Conditions: Pulmonary; Hypertension; Pulmonary Hypoplasia; Congenital Diaphragmatic Hernia
• Interventions: Device: Fetal Tracheal Occlusion

• Registration Number: NCT02986087
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-12-06
• Study First Submitted QC: 2016-12-06
• Study First Posted: 2016-12-08
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-11
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fetal Tracheal Occlusion	Fetal Tracheal Occlusion	Fetuses with severe or moderate congenital diaphragmatic hernia will be offered fetal tracheal occlusion to increase lung growth.

Primary Outcome Measures

Name	Time	Method
Change lung growth on prenatal imaging	prenatal period up to 40 weeks gestation	Change in o/eLHR and other prenatal imaging tests

Secondary Outcome Measures

Name	Time	Method
Change neonatal morbidity	1 year	Change neonatal morbidity
Change need for ECMO therapy	6 months	Change need for ECMO therapy
Change survival in the severe congenital diaphragmatic hernia subgroup	6 months	Change rate of survival
Change pulmonary hypertension	6 months	Change pulmonary hypertension

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center (CCHMC); 🇺🇸 Cincinnati, Ohio, United States