North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia

Обзор

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

Вмешательства

• Устройство 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.
• Другое 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.

Первичные конечные точки

• Number of FETO procedure complications [Срок оценки: 2 years]
• Neonatal survival to discharge [Срок оценки: 2 years]

Вторичные конечные точки (12)

• Presence of pulmonary hypertension [Срок оценки: 6, 12, 18, and 24 months of age]
• Need for supplemental oxygen [Срок оценки: 6, 12, 18, and 24 months of age]
• Periventricular leukomalacia at < 2 months postnatally [Срок оценки: 2 months]
• Intraventricular hemorrhage (grade 0-III) [Срок оценки: 6, 12, 18, and 24 months of age]
• Retinopathy of prematurity (grade 3 or higher) [Срок оценки: 6, 12, 18, and 24 months of age]
• Gastro-esophageal reflux [Срок оценки: 6, 12, 18, and 24 months of age]
• Number of infant hospital readmissions [Срок оценки: 6, 12, 18, and 24 months of age]
• Childhood growth failure [Срок оценки: 6, 12, 18, and 24 months of age]
• Recurrence of Congenital Diaphragmatic Hernia (CDH) repair [Срок оценки: 6, 12, 18, and 24 months of age]
• Bowel obstruction [Срок оценки: 6, 12, 18, and 24 months of age]
• Neurodevelopmental delay [Срок оценки: 6, 12, 18, and 24 months of age]
• Bronchopulmonary dysplasia [Срок оценки: 6, 12, 18, and 24 months of age]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

США · 1 центр

• Mayo Clinic in Rochester — Rochester

Идентификаторы

NCT: NCT07564297 · 25-007786

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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