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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorMayo Clinic

About this trial

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

Eligibility criteria

Qualifiers

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).

Disqualifiers

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

Inability to reside within 30 minutes of Mayo Clinic. and inability to comply with the travel for the follow-up requirements of the trial

Trial design

Treatments tested in this trial

  • Fetoscopic Endoluminal Tracheal Occlusion
  • Standard of Care

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators