Not yet recruiting NCT06946576
Safety and Efficacy of Fetoscopic Endoluminal Tracheal Occlusion in Congenital Diaphragmatic Hernia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fetoscopic Endoluminal Tracheal Occlusion (FETO) Procedure.
- Who it may be relevant to
- Registry conditions: Congenital Diaphragmatic Hernia. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Infant Survival and Long-term Outcomes Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia, A Phase III Trial
Overview
The purpose of this study is to evaluate the safety and efficacy of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in cases of severe Congenital Diaphragmatic Hernia (CDH).
Detailed description
This is an un-blinded, non-randomized, double-arm phase III clinical trial designed to evaluate the safety and efficacy of Fetoscopic Endoluminal Tracheal Occlusion in cases of severe Congenital Diaphragmatic Hernia (CDH) and intrathoracic liver herniation. Patients in the intervention arm will undergo balloon insertion into the fetal trachea between 27 and 30 weeks of gestation. Fetoscopic removal of the balloon occlusion will be performed at 34 weeks gestation.
Interventions
- Device Fetoscopic Endoluminal Tracheal Occlusion (FETO) Procedure
FETO procedure involves insertion of a balloon into the fetal trachea under IV sedation with local anesthesia or combined spinal-epidural anesthesia. Balloon removal will take place up to 7 weeks after insertion.
Primary outcome measures
- Outcomes of placement and removal of FETO device [Time frame: Device placement will take place between 27 weeks 0 days and 29 weeks 6 days gestation. Removal will take place between 34 weeks 0 days and 34 weeks 6 days.]
- Compare survival to discharge between FETO and expectant management [Time frame: Evaluated upon discharge from the NICU (typically 6 months to 1 year after birth)]
- FETO Complications [Time frame: Information about adverse events and complications will take place from study enrollment (gestational age less than 29 weeks) to study conclusion (24 months post-birth)]
Secondary outcome measures (1)
- Long-term mortality and morbidities [Time frame: 6 months, 12 months, 18 months, and 24 months of age]
Eligibility criteria
Inclusion criteria
- Pregnant person age 18 years or older
- Singleton pregnancy
- Normal fetal karyotype with confirmation by culture results, Chromosomal Microarray (CMA) with non-pathological variants, Whole Exome Sequencing (WES) or Whole Genome Sequencing (WGS). Results by florescence in situ hybridization (FISH) will be acceptable if the patient is >26 weeks gestation
- Gestational age at enrollment less than 29 weeks 6 days
- Intrathoracic liver herniation
- Isolated left Congenital Diaphragmatic Hernia (CDH) with Lung to Head Circumference Ratio (LHR) <30% at enrollment OR isolated right CDH with LHR <= 45% at enrollment
- Cervical length by transvaginal ultrasound >= 20 mm within 24 hours of FETO procedure
- Psychosocial criteria
- Able to provide informed consent
Exclusion criteria
- Patient < 18 years of age
- Multi-fetal pregnancy
- History of natural rubber latex allergy
- Preterm labor, cervix shortened (<20 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor or placenta previa
- Psychosocial ineligibility precluding consent
- Inability to reside within 30 minutes of OHSU
- Inability to comply with the travel for the follow-up requirements of the trial
- Lack of a support person (e.g., spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at OHSU.
- Bilateral CDH, isolated left sided CDL with LHR >= 30% or isolated right side CDH with LHR >45% as determined by ultrasound
- No intrathoracic liver herniation
- Additional fetal anomaly and chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (i.e. congenital heart disease) or presence of an underlying genetic syndrome (i.e. Fryns) by ultrasound, MRI, or echocardiogram at the fetal treatment center
- Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
- History of incompetent cervix with or without cerclage
- Placental abnormalities (previa, abruption, accreta) known at time of enrollment
- Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
- Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment
- Uterine anomaly such as large or multiple fibroids or Mullerian duct abnormality
- No safe or technically feasible fetoscopic approach to balloon placement
- Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Oregon Health & Science University — Portland
Identifiers
NCT: NCT06946576 · STUDY00027320