Congenital Diaphragmatic Hernia Clinical Trial
— FETOOfficial title:
Feto-Endoscopic Tracheal Occlusion (FETO) for Left Congenital Diaphragmatic Hernia
NCT number | NCT02986087 |
Other study ID # | 2015-6413 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2016 |
Est. completion date | December 2026 |
Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Children's Hospital Medical Center (CCHMC) | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Medical Center, Cincinnati |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change lung growth on prenatal imaging | Change in o/eLHR and other prenatal imaging tests | prenatal period up to 40 weeks gestation | |
Secondary | Change survival in the severe congenital diaphragmatic hernia subgroup | Change rate of survival | 6 months | |
Secondary | Change need for ECMO therapy | Change need for ECMO therapy | 6 months | |
Secondary | Change pulmonary hypertension | Change pulmonary hypertension | 6 months | |
Secondary | Change neonatal morbidity | Change neonatal morbidity | 1 year |
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