Safety and Efficacy of FETO in CDH: A Phase III Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHolly L Hedrick, MD
About 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.
Eligibility criteria
Qualifiers
Pregnant women age 18 years and older
Singleton pregnancy
Normal fetal karyotype with confirmation by culture results, whole exome sequencing (WES), whole genome sequencing (WGS), or chromosomal microarray with non-pathologic variants. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is greater than 26 weeks.
Gestational age at enrollment is prior to 29 weeks 6 days
Disqualifiers
Patient is less than 18 years of age
Multi-fetal pregnancy
History of natural rubber latex allergy
Preterm labor, cervix shortened (less than 20 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa
Trial design
Treatments tested in this trial
- FETO with GoldBAL2 Balloon and BALTACCIBDPE100 Catheter
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Holly L Hedrick, MD
Lead sponsor
Children's Hospital of Philadelphia
Sponsor institution
Source ClinicalTrials.gov