Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO) (FETO)

  • STATUS
    Recruiting
  • End date
    Aug 1, 2025
  • participants needed
    10
  • sponsor
    Rodrigo Ruano
Updated on 7 October 2022
diaphragmatic hernia
pulmonary hypoplasia

Summary

The purpose of this research is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO).

Details
Condition Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia, Pulmonary Artery Hypertension
Treatment BALT GoldbBAL2 Detachable Balloon, Catheter System
Clinical Study IdentifierNCT03138863
SponsorRodrigo Ruano
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Singleton pregnancy
Normal fetal karyotype with confirmation by culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks
Isolated Left CDH with liver up
Gestation age at enrollment prior to 29 wks plus 6 days severe pulmonary hypoplasia with ultrasound (US) O/E lung area to head circumference ratio (LHR) < 25% (measured at 180 to 296 weeks) at the time of surgery; O/E LHR 25% to <30% (measured at 300 to 316 weeks) at time of surgery
Gestational age at FETO procedure with O/E LHR <25% at 27 weeks 0 days to 29 weeks 6 days; with O/E LHR 25% to <30% at 30 weeks 0 days to 31 weeks 6 days as determined by clinical information (LMP) and evaluation of first ultrasound
Patient meets psychosocial criteria

Exclusion Criteria

Multi-fetal pregnancy
History of natural rubber latex allergy
Preterm labor, cervix shortened (<15 mm at enrollment or within 24 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 minute drive of our hospital, 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 our institution
Right sided CDH or bilateral CDH, isolated left sided with O/E LHR ≥30% (measured at 180 to 295 weeks) as determined by ultrasound
Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram at the fetal treatment center. No cases will be removed post hoc if abnormalities are discovered in the course of postoperative monitoring
Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
History of incompetent cervix with or without cerclage
Placental abnormalities (previa, abruption, accrete) 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
Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy
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