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.
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