Not yet recruiting NCT07564297
North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right 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, Standard of Care.
- Who it may be relevant to
- Registry conditions: Congenital Diaphragmatic Hernia. Basic parameters: 18 years — 50 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 →
Overview
The purpose of this research is to determine if babies who undergo a Fetoscopic Endoluminal Tracheal Occlusion (FETO) procedure survive more often and have less long-term complications than babies who have similarly severe Congenital Diaphragmatic Hernia (CDH) that have not had the FETO procedure performed during pregnancy
Interventions
- Device Fetoscopic Endoluminal Tracheal Occlusion
Mothers who chose to undergo a Fetoscopic Endoluminal Tracheal Occlusion procedure for severe left and right congenital diaphragmatic hernia will be followed until the infant is 2 years of age. - Other Standard of Care
Mothers who chose to receive expectant management for severe left and right congenital diaphragmatic hernia will be followed until the infant is 2 years of age.
Primary outcome measures
- Number of FETO procedure complications [Time frame: 2 years]
- Neonatal survival to discharge [Time frame: 2 years]
Secondary outcome measures (12)
- Presence of pulmonary hypertension [Time frame: 6, 12, 18, and 24 months of age]
- Need for supplemental oxygen [Time frame: 6, 12, 18, and 24 months of age]
- Periventricular leukomalacia at < 2 months postnatally [Time frame: 2 months]
- Intraventricular hemorrhage (grade 0-III) [Time frame: 6, 12, 18, and 24 months of age]
- Retinopathy of prematurity (grade 3 or higher) [Time frame: 6, 12, 18, and 24 months of age]
- Gastro-esophageal reflux [Time frame: 6, 12, 18, and 24 months of age]
- Number of infant hospital readmissions [Time frame: 6, 12, 18, and 24 months of age]
- Childhood growth failure [Time frame: 6, 12, 18, and 24 months of age]
- Recurrence of Congenital Diaphragmatic Hernia (CDH) repair [Time frame: 6, 12, 18, and 24 months of age]
- Bowel obstruction [Time frame: 6, 12, 18, and 24 months of age]
- Neurodevelopmental delay [Time frame: 6, 12, 18, and 24 months of age]
- Bronchopulmonary dysplasia [Time frame: 6, 12, 18, and 24 months of age]
Eligibility criteria
Inclusion criteria
- Singleton pregnancy
- Normal fetal karyotype with confirmation by culture results, CMA with non-pathological variants, WES or WGS. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks
- Gestational age at enrollment prior to 29 6/7 weeks
- Intrathoracic liver herniation Isolated left CDH with O/E LHR < 30% at enrollment (18 0/7 to 29 5/7 weeks.) Isolated right CDH with O/E LHR < 45% at enrollment (18 0/7 to 29 5/7 weeks).
- Cervical length by transvaginal ultrasound > 20 mm within 24 to 48 hours prior to FETO procedure
- Patient meets psychosocial criteria
- Informed consent understood
Exclusion criteria
- Multi-fetal pregnancy
- History of natural rubber latex allergy
- Preterm labor, cervix shortened (<20 mm at enrollment or within 24 to 48 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa
- Psychosocial ineligibility, precluding consent:
- Inability to reside within 30 minutes of Mayo Clinic. and inability to comply with the travel for the follow-up requirements of the trial
- Patient does not have a support person (e.g., spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at Mayo Clinic.
- Bilateral CDH, isolated left sided CDH with O/E LHR 30% (measured at 180 to 295 weeks), isolated right sided CDH with O/E LHR > 45% (measured at 180 to 295 weeks), 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
- There is 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
- Observational model
- Case-control
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT07564297 · 25-007786