What this study is
Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses.
What's being tested
- Fetal Tracheal Occlusion
Intervention · DEVICE
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.
Study details
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Conditions
- Congenital Diaphragmatic Hernia · Pulmonary Hypoplasia · Pulmonary; Hypertension
- Enrolling
- 40 people
- Starts
- 2016-11
- Est. completion
- 2026-12
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 50 YearsSex FEMALEHealthy volunteers AcceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openCincinnati Children's Hospital Medical Center (CCHMC)
Cincinnati, Ohio, United States
- Foong-Yen Lim, MD · Contact513-803-5270Foong.Yen.Lim@cchmc.org
- Jose L Peiro, MD, PhD, MBA · Contact513-803-4563jose.peiroibanez@cchmc.org
- Jose L Peiro, MD, MBA · Sub-investigator
- Foong Y Lim, MD · Principal investigator
Recruiting
Study team
Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID 2015-6413
Study chair
Kurt Schibler, MD
CCHMC Oversight Data Safety Monitoring Committee
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.