Prospective Registry for Long-term Outcomes Following FETO in Severe Left and Right CDH

Recruiting now · Not applicable

Conditions studied: Congenital Diaphragmatic Hernia, Congenital Abnormalities, Neonatal Diseases and Abnormalities, Hernia, DIaphragmatic, Congenital, Internal Hernia, Hernia, Pathological Conditions, Anatomical, Pathological Conditions, Signs and Symptoms

In brief

This registry study aims to confirm that FETO increases neonatal survival to discharge and reduces long-term morbidity in fetuses with isolated left CDH and o/e LHR \< 30%, or isolated right CDH and o/e LHR ≤ 45%, compared to those receiving standard care. This prospective registry plans to enroll 80 pregnant women (40 treatment/40 control) with fetuses diagnosed with isolated CDH, and the children will be followed for up to 24 months.

Key facts

Study ID

NCT07166172

Run by

Johns Hopkins University

People needed

80

Starts

2025-06-23

Expected to finish

2031-12-01

Last updated by the study team

2026-04-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:
• Inability to reside within 30 minutes of Johns Hopkins Hospital Center for Fetal Therapy.
• 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 is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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