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Safety and Efficacy of Fetoscopic Endoluminal Tracheal Occlusion in Congenital Diaphragmatic Hernia

ConditionCongenital Diaphragmatic Hernia
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorOregon Health and Science University

About this trial

The purpose of this study is to evaluate the safety and efficacy of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in cases of severe Congenital Diaphragmatic Hernia (CDH).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pregnant person age 18 years or older

Singleton pregnancy

Normal fetal karyotype with confirmation by culture results, Chromosomal Microarray (CMA) with non-pathological variants, Whole Exome Sequencing (WES) or Whole Genome Sequencing (WGS). Results by florescence in situ hybridization (FISH) will be acceptable if the patient is >26 weeks gestation

Gestational age at enrollment less than 29 weeks 6 days

Disqualifiers

Patient < 18 years of age

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 or placenta previa

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fetoscopic Endoluminal Tracheal Occlusion (FETO) Procedure

    Device

    FETO procedure involves insertion of a balloon into the fetal trachea under IV sedation with local anesthesia or combined spinal-epidural anesthesia. Balloon removal will take place up to 7 weeks after insertion.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Fetal treatment armExperimental treatment 1 intervention
Group B: Expectant management armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Outcomes of placement and removal of FETO device

Whether placement and removal of the FETO device was successful or not

Time frame
Device placement will take place between 27 weeks 0 days and 29 weeks 6 days gestation. Removal will take place between 34 weeks 0 days and 34 weeks 6 days.
2

Compare survival to discharge between FETO and expectant management

Evaluate rates of survival to discharge from the neonatal intensive care units (NICU) between fetuses treated with the FETO and those undergoing expectant management

Time frame
Evaluated upon discharge from the NICU (typically 6 months to 1 year after birth)
3

FETO Complications

Evaluate the frequency of maternal and fetal complications associated with the FETO procedure

Time frame
Information about adverse events and complications will take place from study enrollment (gestational age less than 29 weeks) to study conclusion (24 months post-birth)

Secondary outcomes

1

Long-term mortality and morbidities

Comparison of rates of long-term mortality and morbidities compared between FETO group and those who underwent expectant management.

Time frame
6 months, 12 months, 18 months, and 24 months of age

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oregon Health and Science University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: