Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Официальное название

Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion for Severe Left Congenital Diaphragmatic Hernia

Обзор

The purpose of this research is to gather information on the safety and effectiveness of a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) at Mayo Clinic. The intent of the FETO procedure is to improve development of the lungs in fetuses diagnosed with severe congenital diaphragmatic hernia (CDH).

Вмешательства

• Устройство BALT GOLDBALL 2 detachable latex ballon
  Inflated with fluid in the fetal trachea and provide with the occlusion necessary to promote lung growth.
• Устройство BALTACCIBDPE100 Microcatheter
  Used to deliver the detachable balloon
• Устройство Storz fetoscopic operating sheath and miniature telescope/fetoscope
  Used to percutaneously enter though the maternal abdominal wall, uterus and into the amniotic cavity, fetal mouth, pharynx, larynx, into the trachea where the delivery catheter will be used to deliver the detachable balloon that will provide with the tracheal occlusion.

Первичные конечные точки

• Technical success of the balloon placement procedure [Срок оценки: Up to 29 weeks gestation]
• Technical success of balloon retrieval procedure [Срок оценки: Up to 34 weeks gestation]
• Operative times [Срок оценки: Up to 34 weeks gestation]
• Frequency of unplanned balloon removal [Срок оценки: Up to 34 weeks gestation]
• Number of incidences of maternal complications [Срок оценки: Up to 41 weeks gestation]
• Gestational Age at Delivery [Срок оценки: Up to 41 weeks gestation]

Вторичные конечные точки (12)

• Fetal Lung Growth as measured via Fetal Lung Volume [Срок оценки: Up to 24 months post partum]
• Fetal Lung Growth as measured via LHR [Срок оценки: Up to 24 months post partum]
• Fetal Survival [Срок оценки: Up to 6 months post partum]
• Fetal Oxygen Dependency [Срок оценки: Up to 24 months post partum]
• Occurrence of severe pulmonary hypertension [Срок оценки: Up to 24 months post partum]
• ECMO Support [Срок оценки: Up to 24 months post partum]
• Number of days in NICU [Срок оценки: Up to 24 months post partum]
• Number of days of ventilator support [Срок оценки: Up to 24 months post partum]
• Number of periventricular leukomalacia at < 2 months postnatally [Срок оценки: Up to 2 months post partum]
• Number of infant complications [Срок оценки: Up to 24 months post partum]
• Use of patch or muscle flap [Срок оценки: Up to 24 months post partum]
• Maternal hospitalization [Срок оценки: Up to 24 months post partum]

Критерии участия

Критерии включения

• Singleton pregnancy
• Normal fetal karyotype or microarray. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks
• Isolated severe left CDH with O/E LHR < 25% )
• Gestation age at enrollment prior to 29 wks plus 6 days.
• Pulmonary hypoplasia with ultrasound O/E LHR < 25% (measured at 18 0/7 to 29 5/7 weeks) at the time of surgery.
• Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days as determined by clinical information (LMP) and evaluation of first ultrasound
• Patient meets psychosocial criteria: able to reside within 30 minutes of Mayo Clinic, Rochester and able to comply with the travel for the follow-up requirements of the trial; patient has a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at Mayo Clinic
• Patient is willing and able to give informed consent
• Appropriate multi-disciplinary counseling performed with maternal-fetal medicine, neonatology, pediatric surgery, genetics, pediatric otolaryngology (ENT)

Критерии исключения

• 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
• Psychosocial ineligibility, precluding consent: inability to reside within 30 minutes of Mayo Clinic, Rochester 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
• Right sided CDH or bilateral CDH, isolated left sided with O/E LHR >25% measured at 18 0/7 to 29 6/7 weeks) as determined by ultrasound
• Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram that will significantly worsen prognosis. No cases will be removed post hoc if abnormalities are discovered in the course of post-operative monitoring
• Maternal contraindication to fetoscopic surgery
• 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.
• Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality that will make the procedure technically unfeasible
• 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

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Mayo Clinic Minnesota — Rochester

Идентификаторы

NCT: NCT05962346 · 23-002166

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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