Feto-Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorChildren's Hospital Medical Center, Cincinnati
About this trial
Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Fetal Tracheal Occlusion
Treatment groups
40 Participants
are divided into 1 treatment groupLocations
1Cincinnati Children's Hospital Medical Center (CCHMC)45229, CincinnatiOhio, United States
Sponsors and collaborators
Children's Hospital Medical Center, Cincinnati
Lead sponsor
Source ClinicalTrials.gov