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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
FETO with GoldBAL2 Balloon and BALTACCIBDPE100 Catheter
DeviceFetoscopic Endoluminal Tracheal Occlusion (FETO) in CDH with GoldBAL2 Detachable Balloon and BALTACCIBDPE100 Delivery Catheter
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: FETO in CDHExperimental treatment 1 intervention
Group B: Expectant Management in CDHNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Successful placement and removal of the FETO Device
Evalutation of successful placement and removal of the fetoscopic endoluminal tracheal occlusion (FETO) device in cases of intrathoracic liver herniation with isolated left congenital diaphragmatic hernia (LCDH) with observed/expected lung to head ratio (O/E LHR) \< 30% or isolated right congenital diaphragmatic hernia (RCDH) with O/E LHR \< 45%.
Time frame
24 months2
Comparison of neonatal survival rates of LCDH cases between intervention and control groups
Compare survival to discharge from the neonatal intensive care units (NICU), between fetuses with intrathoracic liver herniation and isolated LCDH with O/E LHR \< 30% that receive FETO procedure performed at 27\^0 to 29\^6 weeks gestation to concurrent patients with intrathoracic liver herniation, isolated LCDH and O/E LRH \< 30% that undergo expectant management.
Time frame
24 months3
Comparison of neonatal survival rates of RCDH cases between intervention and control groups
Compare the neonatal survival rate to discharge from the neonatal intensive care units (NICU), between fetuses with intrathoracic liver herniation, isolated RCDH with O/E LHR \< 45% that undergo FETO procedure performed at 27\^0 to 29\^6 weeks gestation to concurrent patients with intrathoracic liver herniation, isolated RCDH and O/E LHR \< 45% that proceed with expectant management.
Time frame
24 months4
Assessment of complications associated with the FETO intervention
Evaluate the frequency of maternal and fetal complications associated with the FETO intervention.
Time frame
24 monthsSecondary outcomes
1
Comparison of long-term mortality and morbidity of LCDH cases between intervention and control groups
Evaluate whether the FETO procedure is associated with reduced long-term mortality and morbidities at 6, 12, 18 and 24 months in isolated LCDH survivors with O/E LHR \< 30% when compared to concurrent isolated LCDH with O/E LRH \< 30% that undergo expectant management where all fetuses were found to have intrathoracic liver herniation.
Time frame
24 months2
Comparison of long-term mortality and morbidity of RCDH cases between intervention and control groups
Evaluate whether the FETO procedure is associated with reduced long-term mortality and morbidities at 6, 12, 18, and 24 months in isolated RCDH survivors with O/E LHR ≤ 45% when compared to concurrent isolated RCDH with LHR ≤ 45% that undergo expectant management where all fetuses were found to have intrathoracic liver herniation.
Time frame
24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Holly L Hedrick, MD
Lead sponsor
Children's Hospital of Philadelphia
Sponsor institution
Source ClinicalTrials.gov