Long-term outcomes after FETO for severe left or right congenital diaphragmatic hernia
Official title: North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
Run by Johns Hopkins University · NCT07166172 · Data updated 2026-11-12
This trial will test whether performing FETO in fetuses with isolated severe left or right CDH helps more babies survive to hospital discharge and have fewer long-term problems than standard care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 80 (estimated) |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Status | Recruiting |
| Started | June 23, 2025 |
| Main results expected | December 1, 2029 |
| Study ends | December 1, 2031 |
| Registry record updated | April 23, 2026 |
| Trial ID | NCT07166172 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pregnant people aged 18 or older with a singleton fetus, normal genetic testing, and an isolated left CDH with o/e LHR < 30% or isolated right CDH with o/e LHR ≤ 45% who present before 29+6 weeks' gestation.
✕Probably not a fit
Patients with multifetal pregnancies, significant genetic abnormalities, active preterm labor, a shortened cervix below entry criteria, or other listed exclusions are unlikely to benefit or be eligible for the procedure.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective registry will enroll 80 pregnant people with fetuses diagnosed with isolated left CDH (o/e LHR < 30%) or isolated right CDH (o/e LHR ≤ 45%) and compare 40 who undergo FETO with 40 who receive expectant management. The FETO procedure is planned between 27+0 and 29+6 weeks' gestation with device placement and later removal per protocol. The study will track survival to neonatal intensive care unit discharge, maternal and fetal complications related to the procedure, and longer-term morbidity. Children will be followed for up to 24 months to capture survival, respiratory, and developmental outcomes.
Why it matters
Potential benefit: If successful, FETO could increase newborn survival and reduce long-term respiratory and developmental problems for severe isolated CDH.
How similar studies have gone: Prior observational series and program reports have shown improved short-term survival after FETO for severe left CDH, but long-term benefits and definitive randomized evidence remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women age 18 years and older * Singleton pregnancy * Normal Karyotype, chromosomal microanalysis (CMA) with non-pathologic variants, whole exome sequencing (WES) or whole genome sequencing (WGS). Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \> 26 weeks gestation. * Gestational age at enrollment is prior to 29 weeks + 6 days gestation. * Intrathoracic liver herniation: * Isolated left CDH with o/e LHR \< 30% at enrollment (18wks + 0 days to 29wks + 5 days gestation). * Isolated right CDH with o/e LHR ≤ 45% at enrollment (18wks + 0 days to 29wks + 5 days gestation). * Cervical length by transvaginal ultrasound ≥ 20 mm within 24 hours prior to FETO procedure. * Patient meets psychosocial criteria. * Informed consent understood. Exclusion Criteria: * 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 of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa. * Psychosocial ineligibility, precluding consent: 1. Inability to reside within 30 minutes of Johns Hopkins Hospital Center for Fetal Therapy. 2. 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 Johns Hopkins Hospital Center for Fetal Therapy. * Bilateral CDH, isolated left sided CDH with O/E LHR ≥ 30% (18wks + 0 days to 29wks + 5 days gestation), isolated right sided CDH with O/E LHR \> 45% (18wks + 0 days to 29wks + 5 days gestation), as determined by ultrasound. * No liver herniation into thoracic cavity. * Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram at the fetal treatment center. Exclude chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (i.e., CDH and congenital heart disease) or presence of an underlying genetic syndrome (i.e., Fryns). * Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy. * History of incompetent cervix with or without cerclage. * Placental abnormalities (previa, abruption, accreta) known at time of enrollment * Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy. * Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment. * Uterine anomalies such as large or multiple fibroids or Mullerian duct abnormality. * There is 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 it's running
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Johns Hopkins Hospital
Baltimore, Maryland, United States Recruiting
Study contacts
- Principal investigator: Ahmet Baschat, MD — Johns Hopkins University
- Study coordinator: Ahmet Baschat, MD
- Email: abascha1@jhmi.edu
- Phone: 410-502-6561
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.