Feto-Endoscopic Tracheal Occlusion (FETO) for Left Congenital Diaphragmatic Hernia

Study Purpose

Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 50 Years
Gender	Female

More 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02986087
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Children's Hospital Medical Center, Cincinnati
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Kurt Schibler, MD
Principal Investigator Affiliation	CCHMC Oversight Data Safety Monitoring Committee
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia, Pulmonary; Hypertension

Additional Details

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.

Arms & Interventions

Arms

Experimental: Fetal Tracheal Occlusion

Fetuses with severe or moderate congenital diaphragmatic hernia will be offered fetal tracheal occlusion to increase lung growth.

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 as a requirement to enter the TOTAL trial.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cincinnati, Ohio

Status

Recruiting

Address

Cincinnati Children's Hospital Medical Center (CCHMC)

Cincinnati, Ohio, 45229

Site Contact

Foong-Yen Lim, MD

Foong.Yen.Lim@cchmc.org

513-803-5270