RECRUITING

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

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Conditions

Congenital Diaphragmatic Hernia

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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

The purpose of the study is to study the efficacy of fetal endoscopic tracheal occlusion (FETO) in cases of severe congenital diaphragmatic hernia (CDH). This study will also collect safety and effectiveness data for the off-label use of the FETO Goldballoon (the balloon that will be inserted into the fetal trachea), manufactured by Balt medical. The investigators hope to study the risks and benefits of FETO in cases of severe CDH in an advanced medical center such as Lucile Packard Children's Hospital (LPCH) Stanford with access to advanced maternal-fetal medicine, neonatal services, and neonatal ECMO, and pediatric surgery.

Official Title

A Study of the Effectiveness of Fetal Endoscopic Tracheal Occlusion (FETO) in the Management of Severe Prenatally Diagnosed Congenital Diaphragmatic Hernia (CDH)

Quick Facts

Study Start:2023-04-17
Study Completion:2027-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05461222

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 to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Maternal Age: 18-50
  2. * Singleton gestation
  3. * Gestational age before 29 weeks 6 days
  4. * Severe left or right-sided CDH: For severe left sided CDH observed-to-expected lung-to- head ratio (o/e LHR) less than 25% between 22 and 29 6/7 weeks' gestation, liver herniation, MRI lung volumes less than 30% expected based on gestational age nomograms. For severe right sided CDH o/e LHR less than 30 % between 22 and 29 6/7 weeks' gestation, liver herniation, MRI lung volumes less than 30% expected based on gestational age nomograms.
  5. * Normal genetic karyotype or microarray testing by amniocentesis or chorionic villus sampling (CVS)
  6. * Absence of associated fetal structural cardiac anomalies by a dedicated fetal echocardiogram
  7. * Absence of other structural anomalies by ultrasound or MRI
  8. * Appropriate multi-disciplinary counseling performed with maternal-fetal medicine, neonatology, pediatric surgery, genetics, pediatric otolaryngology (ENT).
  9. * Must be willing to remain near LPCH Stanford (within 30 minutes from the hospital) for the duration of the balloon placement.
  10. * No maternal and/or fetal contra-indications to fetal surgery such as a bleeding disorder, poorly controlled diabetes or hypertension, short cervix (measuring \< 20mm), risk for preterm birth etc.
  11. * Planned pregnancy surveillance at LPCH Stanford
  12. * Planned delivery at LPCH Stanford
  13. * Able to provide written consent
  14. * Willingness to comply with all study procedures and availability (meets psychosocial criteria) for the duration of the study including having a support person
  1. * Contraindications to fetal surgery including poorly controlled hypertension, diabetes or other maternal medical condition including hematological disorder
  2. * High risk for preterm labor and/or delivery based on either significant history of preterm birth, short cervix (measuring \< 20mm), significant uterine anomaly or other risk factor, incompetent cervix (requiring cerclage)
  3. * Non-isolated CDH - CDH with additional structural anomalies
  4. * Significant maternal obesity defined as a body mass index (BMI) greater than 40. BMI is a calculation which includes a person's height and weight
  5. * History of natural rubber latex allergy
  6. * Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality
  7. * Participation in another intervention study that influences maternal and fetal morbidity and mortality.
  8. * Bilateral CDH, left-sided CDH with O/E LHR \>25%, or left-sided CDH with O/E LHR \<25% but liver completely down in abdomen
  9. * Right-sided CDH O/E LHR \>30% or right-sided CDH with O/E LHR \<30% with liver completely down in abdomen
  10. * Significant placental abnormalities (abruption, chorioangioma, accreta) known at the time of enrollment and/or surgery
  11. * Maternal-fetal Rhesus isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia, affecting the current pregnancy.
  12. * 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
  13. * No safe or feasible fetoscopic approach to balloon placement.

Contacts and Locations

Principal Investigator

Yair Blumenfeld, MD
PRINCIPAL_INVESTIGATOR
Stanford University

Study Locations (Sites)

Lucile Packard Children's Hospital
Stanford, California, 94305-6070
United States

Collaborators and Investigators

Sponsor: Yair Blumenfeld

  • Yair Blumenfeld, MD, PRINCIPAL_INVESTIGATOR, Stanford 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 Date2023-04-17
Study Completion Date2027-08-31

Study Record Updates

Study Start Date2023-04-17
Study Completion Date2027-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Congenital Diaphragmatic Hernia