Congenital Diaphragmatic Hernia Clinical Trial
Official title:
A Pilot Study on the Role of Fetal Endotracheal Occlusion (FETO) in Fetuses With Severe Congenital Diaphragmatic Hernia
The goal of this pilot trial is to learn more about the role of Fetal Endotracheal Occlusion (FETO) as an intervention in fetuses with severe congenital diaphragmatic hernia (CDH). The research team will investigate the feasibility and safety of the FETO procedure, as well as determine whether FETO can improve lung growth before birth, and survival after birth. This study will enroll 10 pregnant participants to undergo the FETO procedure at a gestational age of 27 weeks 0 days to 29 weeks 6 days. The participant will be monitored for a few weeks, and then the FETO removal procedure will be performed ideally at 34 weeks 0 days to 34 weeks 6 days, but may be indicated earlier as determined by the Maternal Fetal care team. The pregnant participant and their baby will continue to be monitored during delivery and up until the child reaches 2 years of age.
The goal of this study is to learn more about the role of Fetal Endotracheal Occlusion (FETO) as an intervention in fetuses with isolated severe congenital diaphragmatic hernia (CDH). CDH is a condition in which the diaphragm fails to completely close, leaving a gap through which abdominal organs can herniate and slide into and out of the chest. In severe cases, abdominal organs move into the chest and stay there, putting pressure on the heart and lungs and potentially causing the disruption or deformation of these structures. Impaired development of the lungs can often lead to a condition known as pulmonary hypertension, a form of high blood pressure that damages the heart. Pulmonary hypoplasia and pulmonary hypertension can be lethal. Congenital diaphragmatic hernia (CDH) affects 1 in 2,200 to 5,000 live births per year. FETO will be performed with the goal of promoting lung growth and improving neonatal outcomes. FETO is a minimally invasive procedure in which a balloon device is inserted into the trachea of the fetus. The devices involved are the Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100). The balloon would be left in place for several weeks and allow the lungs to grow, after which it would be removed, enabling the lungs to mature before birth. Participants will continue to be monitored up until the child reaches 2 years of age in order to assess mental and physical development after FETO. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05100693 -
Smart Removal for Congenital Diaphragmatic Hernia
|
N/A | |
| Recruiting |
NCT05450653 -
Trial of FETO for Severe Congenital Diaphragmatic Hernia
|
N/A | |
| Terminated |
NCT04140669 -
Automated Myocardial Performance Index Using Samsung HERA W10
|
||
| Recruiting |
NCT05201144 -
A Trial of Phosphodiesterase-5 Inhibitor in Neonatal Congenital Diaphragmatic Hernia (TOP-CDH)
|
Phase 2 | |
| Recruiting |
NCT04429750 -
Intact Cord Resuscitation in CDH
|
N/A | |
| Recruiting |
NCT03750266 -
3D Animation and Models to Aid Management of Fetal CDH
|
||
| Not yet recruiting |
NCT05421676 -
Fetal Endoscopic Tracheal Occlusion for CDH (CDH)
|
N/A | |
| Completed |
NCT01243229 -
Genetic Analysis of Congenital Diaphragmatic Disorders
|
||
| Recruiting |
NCT04583644 -
Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)
|
N/A | |
| Completed |
NCT03314233 -
Delayed Cord Clamping for Congenital Diaphragmatic Hernia
|
N/A | |
| Recruiting |
NCT04114578 -
Exploratory Observational Prospective Study in Neonatal and Pediatric Congenital Diaphragmatic Hernia
|
||
| Completed |
NCT03666767 -
Management and Outcomes of Congenital Anomalies in Low-, Middle- and High-Income Countries
|
||
| Recruiting |
NCT02986087 -
Feto-Endoscopic Tracheal Occlusion (FETO) for Left Congenital Diaphragmatic Hernia
|
N/A | |
| Recruiting |
NCT03674372 -
Fetoscopic Endoluminal Tracheal Occlusion
|
N/A | |
| Active, not recruiting |
NCT05839340 -
Neurally Adjusted Ventilatory Assist for Neonates With Congenital Diaphragmatic Hernias
|
N/A | |
| Enrolling by invitation |
NCT05962346 -
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
|
N/A | |
| Withdrawn |
NCT04186039 -
Functional Evaluation of the Fetal Lung by Functional Magnetic Resonance Imaging - Blood Oxygenation Level Dependent (MRI-BOLD), in Congenital Diaphragmatic and Parietal Malformations
|
N/A | |
| Unknown status |
NCT01302977 -
Fetal Tracheal Occlusion in Severe Diaphragmatic Hernia: a Randomized Trial
|
Phase 2 | |
| Recruiting |
NCT03179371 -
Proteomic Profiling for Congenital Diaphragmatic Hernia
|
||
| Recruiting |
NCT03138863 -
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO)
|
N/A |