Fetal tracheal occlusion for severe congenital diaphragmatic hernia
Feto-Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia
This study is testing if a procedure called fetal tracheal occlusion can help improve lung development in unborn babies with severe congenital diaphragmatic hernia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT02986087 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility and efficacy of fetal tracheal occlusion (FETO) in fetuses diagnosed with severe congenital diaphragmatic hernia (CDH) characterized by liver-up and significant pulmonary hypoplasia. Eligible participants include singleton pregnancies with specific ultrasound findings and gestational age criteria. The intervention aims to improve lung development and overall outcomes for affected fetuses. The study is conducted at Cincinnati Children's Hospital Medical Center, focusing on a targeted patient population.
Who should consider this trial
Good fit: Ideal candidates are pregnant individuals with a singleton fetus diagnosed with severe congenital diaphragmatic hernia and specific ultrasound criteria.
Not a fit: Patients with multi-fetal pregnancies or those under 18 years old will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve lung development and survival rates for fetuses with severe congenital diaphragmatic hernia.
How similar studies have performed: Other studies have shown promise with fetal interventions for congenital diaphragmatic hernia, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cincinnati, Ohio
- Cincinnati Children's Hospital Medical Center (CCHMC) — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Foong-Yen Lim, MD
- Email: Foong-Yen.Lim@cchmc.org
- Phone: (513) 636-6259
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.