Overview
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.
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