FETO for Congenital Diaphragmatic Hernia
(CHOP FETO Trial)
Trial Summary
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment FETO for Congenital Diaphragmatic Hernia?
Research shows that FETO (fetoscopic endoluminal tracheal occlusion) significantly improves survival rates in babies with severe congenital diaphragmatic hernia (CDH). A meta-analysis of randomized controlled trials found that FETO increased survival rates compared to standard care, with a notable improvement in outcomes for those with severe cases.12345
How does the FETO treatment for congenital diaphragmatic hernia differ from other treatments?
FETO (fetoscopic endotracheal occlusion) is a unique prenatal treatment for congenital diaphragmatic hernia (CDH) that involves blocking the fetus's windpipe to promote lung growth before birth, which is different from traditional postnatal surgical repairs. This approach aims to increase survival rates in severe cases of CDH by addressing the condition while the baby is still in the womb.12678
What is the purpose of this trial?
Congenital diaphragmatic hernia (CDH) is a birth defect characterized by the development of a hole in the diaphragm, the breathing muscle that separates the chest from the abdomen. As a result, organs in the abdomen can move into the chest and press on the developing lungs. This prevents the lungs from growing and developing normally.In severe cases, CDH can lead to serious disease and death at birth. For these babies, treatment before birth may allow the lungs to grow enough before birth so these children are capable of surviving and thriving.
Research Team
Holly L Hedrick, MD, FACS
Principal Investigator
Children's Hospital of Philadelphia
Eligibility Criteria
This trial is for pregnant women over 18 with a single pregnancy and a fetus diagnosed with severe Congenital Diaphragmatic Hernia (CDH). Eligible participants must be before 29 weeks and 6 days of gestation, have no major health issues or contraindications to surgery, and be able to stay near the hospital. Those with multiple pregnancies, latex allergies, additional fetal anomalies, or other medical conditions that could affect surgery safety are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Prenatal Evaluation
Standard prenatal evaluation including medical history, physical exam, ultrasound, echocardiogram, MRI, and psychosocial assessment
FETO Intervention
Placement of a detachable balloon in the fetal airway between 27+0/7 - 29+6/7 gestational age, with removal between 34+0/7 - 34+6/7 gestational age
Postnatal Stabilization and Surgery
Postnatal stabilization and subsequent surgery to repair the diaphragm at CHOP
Follow-up
Infants are monitored for safety and effectiveness at 6, 12, 18, and 24 months of age
Treatment Details
Interventions
- FETO
Find a Clinic Near You
Who Is Running the Clinical Trial?
Holly L Hedrick, MD
Lead Sponsor