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

Recruiting N/A Interventional Study
Congenital Diaphragmatic Hernia Congenital Abnormalities Neonatal Diseases and Abnormalities Hernia, DIaphragmatic, Congenital Internal Hernia Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
Johns Hopkins University · Other
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About This Trial
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 childre…
Trial Locations
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Eligibility 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 …
Contacts

Ahmet Baschat, MD

410-502-6561

abascha1@jhmi.edu

CONTACT