Fetoscopic Endoluminal Tracheal Occlusion
ConditionHernia, DIaphragmatic, Congenital
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorChildren's Hospitals and Clinics of Minnesota
About this trial
This is a single site pilot trial to study the feasibility of Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most severe group of fetuses with congenital diaphragmatic hernia (CDH) at Midwest Fetal Care Center, a collaboration between Allina Health and Children's Minnesota. This procedure aims to increase fetal lung volume before birth and improve survival after birth. This study will enroll 10 pregnant people and their baby who meet study criteria.
Eligibility criteria
Qualifiers
A subject is defined as a female (18 years or older) who is pregnant.
The pregnancy must be a singleton pregnancy.
The CDH must be left-sided.
The CDH must be severe (Observed to Expected Lung to Head Ratio - O/E LHR - < 25% from U/S measurements).
Disqualifiers
Twin or higher order gestation
Not able to consent
Right-sided or bilateral CDH
Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome
Trial design
Treatments tested in this trial
- FETO therapy
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Children's Hospitals and Clinics of Minnesota
Lead sponsor
Allina Health System
Collaborator
Source ClinicalTrials.gov