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

Cincinnati Children's Hospital Medical Center

Status

Enrolling

Conditions

Pulmonary; Hypertension

Pulmonary Hypoplasia

Congenital Diaphragmatic Hernia

Treatments

Device: Fetal Tracheal Occlusion

Study type

Interventional

Funder types

Other

Identifiers

NCT02986087

2015-6413

Details and patient eligibility

About

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

Full 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.

Enrollment

40 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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