Congenital Diaphragmatic Hernia, Pulmonary; Hypertension, Pulmonary Hypoplasia
Conditions
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.
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.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change lung growth on prenatal imaging | prenatal period up to 40 weeks gestation | Change in o/eLHR and other prenatal imaging tests |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change survival in the severe congenital diaphragmatic hernia subgroup | 6 months | Change rate of survival |
| Change need for ECMO therapy | 6 months | Change need for ECMO therapy |
| Change pulmonary hypertension | 6 months | Change pulmonary hypertension |
| Change neonatal morbidity | 1 year | Change neonatal morbidity |
Countries
United States
Contacts
Primary ContactFoong-Yen Lim, MD
Backup ContactJose Peiro, MD, PhD
Outcome results
None listed