NCT02986087 · Children's Hospital Medical Center, Cincinnati
Feto-Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia
(FETO)
What this study is about
Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses.
View original scientific description
Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses.
Interventions
DEVICE
Fetal 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.
Primary outcome measures
Change lung growth on prenatal imaging
Time frame: prenatal period up to 40 weeks gestation
Change in o/eLHR and other prenatal imaging tests
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Cincinnati, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 11, 2025 · Source of record for eligibility and locations