RECRUITING

Trial of FETO for Severe Congenital Diaphragmatic Hernia

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Conditions

Congenital Diaphragmatic HerniaHernia, Diaphragmatic, CongenitalFetal Endoscopic Tracheal OcclusionFetoscopic Endoluminal Tracheal OcclusionPregnantHumansFetoscopy

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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 pilot trial to study the feasibility of Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most severe group of fetuses with congenital diaphragmatic hernia (CDH) at Ann \& Robert H. Lurie Children's Hospital of Chicago (Lurie Children's). This procedure aims to increase fetal lung volume before birth and improve survival after birth. This study will enroll 10 pregnant women who meet study criteria.

Official Title

Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Fetuses With Severe Congenital Diaphragmatic Hernia (CDH)

Quick Facts

Study Start:2022-09-18
Study Completion:2027-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05450653

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:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated informed consent form
  2. * Pregnant individuals age 18 years and older
  3. * Singleton pregnancy
  4. * No pathogenic variants on prenatal chromosomal microarray or pathologic findings on karyotype analysis. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \> 26 weeks
  5. * Isolated left or right CDH with severe pulmonary hypoplasia with o/e LHR \<25% with liver up (measured at 18 weeks 0 days to 29 weeks 5 days of gestation)
  6. * Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days as determined by clinical information and evaluation of first ultrasound
  7. * Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects
  8. * Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
  9. * Willingness to reside within 30 minutes of the Chicago Institute for Fetal Health (CIFH) in the time period between the FETO placement procedure and the balloon retrieval procedure and ability to maintain follow up appointments
  10. * Subject has a support person (e.g., spouse, partner, friend, parent) that is available to stay with her for the duration of the pregnancy near Lurie Children's
  11. * Willingness to comply with study restrictions on work, exercise, and intercourse
  12. * Meets psychosocial criteria
  1. * Rubber latex allergy
  2. * Presence of chromosomal abnormalities or anatomic anomalies that are known to significantly alter survival prognosis (i.e., CDH and congenital heart disease). No cases will be removed post hoc if abnormalities are discovered during post-operative monitoring
  3. * History of preterm labor, cervix shortened to ≤20 mm at enrollment or at 24 hours prior to FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor or placenta previa
  4. * Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
  5. * History of incompetent cervix with or without cerclage
  6. * Placental abnormalities (previa, abruption, accreta, chorioangioma) known at time of enrollment
  7. * Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
  8. * 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
  9. * Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality
  10. * There is no safe or technically feasible fetoscopic approach to balloon placement
  11. * Participation in another intervention study that influences maternal and fetal morbidity and mortality
  12. * Any other condition which, in the opinion of the investigator, would compromise safety, feasibility or impede compliance

Contacts and Locations

Study Contact

Aimen Shaaban, MD
CONTACT
312-227-4747
AShaaban@luriechildrens.org

Principal Investigator

Aimen Shaaban, MD
PRINCIPAL_INVESTIGATOR
Ann & Robert H Lurie Children's Hospital of Chicago

Study Locations (Sites)

Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Aimen F. Shaaban, MD

  • Aimen Shaaban, MD, PRINCIPAL_INVESTIGATOR, Ann & Robert H Lurie Children's Hospital of Chicago

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 Date2022-09-18
Study Completion Date2027-11

Study Record Updates

Study Start Date2022-09-18
Study Completion Date2027-11

Terms related to this study

Keywords Provided by Researchers

  • Hernia, Diaphragmatic, Congenital
  • Fetal Endoscopic Tracheal Occlusion
  • Fetoscopic Endoluminal Tracheal Occlusion
  • Pregnant
  • Humans
  • Fetoscopy

Additional Relevant MeSH Terms

  • Congenital Diaphragmatic Hernia