RECRUITING

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

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Conditions

Diaphragmatic HerniaFetal Endoscopic Tracheal Occlusion (FETO)Congenital diaphragmatic hernia (CDH)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a single site, single arm, non-randomized, pilot trial to assess the feasibility and safety of treating severe congenital diaphragmatic hernia (CDH) with Fetal Endoscopic Tracheal Occlusion (FETO) at Columbia University Irving Medical Center (CUIMC)/ NewYork-Presbyterian Hospital (NYP).

Official Title

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

Quick Facts

Study Start:2025-09
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05354505

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Provision of signed and dated informed consent form
  2. 2. Stated willingness to comply with all study procedures and availability (meets psychosocial criteria below) for the duration of the study
  3. 3. Pregnant women, age 18 years and older
  4. 4. Singleton pregnancy
  5. 5. No pathogenic variants on microarray or pathologic findings on karyotype; results by fluorescence in situ hybridization (FISH) will be acceptable if patient is \>26 weeks
  6. 6. Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects
  7. 7. Fetal CDH (left or right) with severe pulmonary hypoplasia, defined as o/e LHR \<25% with liver up
  8. 8. Gestational age at FETO procedure: if o/e LHR \<25%, will be done at 27 weeks plus 0 days to 29 weeks plus 6 days
  9. 9. Meets psychosocial criteria
  10. * Willing to reside within 30 minutes of NewYork-Presbyterian Sloane Hospital for Women/Columbia University Irving Medical Center (CUIMC) and ability to maintain follow up appointments. NYP/CUIMC will work with the study participant to assist in securing housing 30 minutes from the hospital if this is a challenge to her.
  11. * Patient has a support person (e.g. spouse, partner, friend, parent) that is available to stay with her for the duration of the pregnancy near NewYork-Presbyterian Sloane Hospital for Women/Columbia University Irving Medical Center (CUIMC)
  12. * Willing to comply with restrictions of daily living including inability to exercise, have intercourse, or return to work
  1. 1. Multi-fetal pregnancy
  2. 2. History of latex allergy
  3. 3. History of preterm labor or incompetent cervix (requiring cerclage), short cervix (\<20mm), or uterine anomaly predisposing to preterm labor
  4. 4. Psychosocial ineligibility
  5. * Inability to reside within 30 minutes of NewYork-Presbyterian Sloane Hospital for Women/Columbia University Irving Medical Center (CUIMC) or inability to maintain follow up appointments
  6. * Social work will meet with each patient to evaluate the social situation and support system. Identifiable issues of social instability or compliance with the protocol will exclude her as a potential candidate.
  7. 5. Bilateral CDH, unilateral CDH with o/e LHR \> 25%, or unilateral CDH with o/e LHR \<25% but liver completely down in abdomen
  8. 6. Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome
  9. 7. Maternal contraindications to elective fetoscopic surgery
  10. 8. Significant placental abnormalities (abruption, chorioangioma, accreta) known at time of enrollment and/or surgery
  11. 9. Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy.Maternal HIV, Hepatitis B with positive surface antigen, Hepatitis C with presence of virus in maternal blood due to risk of fetal transmission during the procedure
  12. 10. No safe or feasible fetoscopic approach to balloon placement
  13. 11. Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality
  14. 12. Participation in another intervention study that influences maternal and fetal morbidity and mortality.

Contacts and Locations

Study Contact

Amanda Alonso, MHA
CONTACT
212-342-0261
aa2974@cumc.columbia.edu

Principal Investigator

Vincent Duron, MD
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

Columbia University Irving Medical Center/NewYork-Presbyterian
New York, New York, 11021
United States

Collaborators and Investigators

Sponsor: Vincent Duron

  • Vincent Duron, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09
Study Completion Date2027-06

Study Record Updates

Study Start Date2025-09
Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

  • Fetal Endoscopic Tracheal Occlusion (FETO)
  • Congenital diaphragmatic hernia (CDH)

Additional Relevant MeSH Terms

  • Diaphragmatic Hernia