RecruitingNot ApplicableNCT02986087

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

Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

40 participants

Start Date

Nov 1, 2016

Study Type

INTERVENTIONAL

Conditions

Pulmonary Hypertension Congenital Diaphragmatic Hernia Pulmonary Hypoplasia

Summary

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

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria13

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 Criteria14

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

Interventions

DEVICEFetal 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.