RecruitingCongenital Diaphragmatic HerniaPulmonary HypoplasiaPulmonary Hypertension

Safety and Efficacy of FETO in CDH Phase III

Eligible age

18–50 yrs

Accepts

Women

Locations

1 state

Healthy volunteers

Yes

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Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses and standard of care control group

Sponsor: Children's Hospital Medical Center, Cincinnati

✓ Pregnant women 18 years and older, who are able to consent
✓ Singleton pregnancy
✓ Gestational age at enrollment is prior to 296 weeks
✓ Intrathoracic liver herniation
✓ Isolated Left CDH with o/e LHR \< 30% at enrollment (180 to 295 weeks) or
✓ Isolated Right CDH with o/e LHR \< 45% at enrollment (180 to 295 weeks)
✓ Normal fetal karyotype with confirmation by culture results, CMA with non-pathological variants, WES or WGS. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \> 26 weeks
✓ Cervical length by transvaginal ultrasound \> 20 mm within 24 hours prior to FETO procedure

✕ Patient \< 18 years of age
✕ Multi-fetal pregnancy
✕ History of natural rubber latex allergy
✕ Preterm labor, cervix shortened (\< 20 mm at enrollment or within 24 hours prior to FETO balloon insertion) or uterine anomaly strongly predisposing to preterm labor, or placenta previa.
✕ Psychosocial ineligibility, precluding consent:
✕ Inability to reside within 30 minutes of Cincinnati Children's Hospital Medical Center and inability to comply with the travel for the follow-up requirements of the trial.
✕ The patient does not have a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at Cincinnati Children's Hospital Medical Center.
✕ Bilateral CDH, isolated LCDH with o/e LHR ≥ 30%, isolated RCDH with o/e LHR \> 45%, as determined by ultrasound.

Cincinnati

Source: ClinicalTrials.gov · NCT07187206 · last updated 2025-09-22