Fetal endoscopic tracheal occlusion for severe congenital diaphragmatic hernia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-site, single-arm pilot at Columbia University/NewYork-Presbyterian testing the feasibility and safety of Fetal Endoscopic Tracheal Occlusion (FETO) using the GOLDBAL2 balloon for fetuses with severe CDH. Eligible pregnancies are singleton, genetically normal fetuses with severe pulmonary hypoplasia (o/e LHR <25% with liver up) and the procedure is scheduled between 27+0 and 29+6 weeks' gestation. The trial will track procedure-related safety, fetal lung growth, timing of delivery, and early neonatal outcomes after balloon placement and removal. Participants must remain local for follow-up and meet psychosocial criteria required by the center.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability (meets psychosocial criteria below) for the duration of the study
3. Pregnant women, age 18 years and older
4. Singleton pregnancy
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. Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects
7. Fetal CDH (left or right) with severe pulmonary hypoplasia, defined as o/e LHR \<25% with liver up
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. Meets psychosocial criteria

   * 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.
   * 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)
   * Willing to comply with restrictions of daily living including inability to exercise, have intercourse, or return to work

Exclusion Criteria:

1. Multi-fetal pregnancy
2. History of latex allergy
3. History of preterm labor or incompetent cervix (requiring cerclage), short cervix (\<20mm), or uterine anomaly predisposing to preterm labor
4. Psychosocial ineligibility

   * 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
   * 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.
5. Bilateral CDH, unilateral CDH with o/e LHR \> 25%, or unilateral CDH with o/e LHR \<25% but liver completely down in abdomen
6. Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome
7. Maternal contraindications to elective fetoscopic surgery
8. Significant placental abnormalities (abruption, chorioangioma, accreta) known at time of enrollment and/or surgery
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
10. No safe or feasible fetoscopic approach to balloon placement
11. Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality
12. Participation in another intervention study that influences maternal and fetal morbidity and mortality.

Where it's running

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

Study contacts

• Principal investigator: Vincent Duron, MD — Columbia University
• Study coordinator: Amanda Alonso, MHA
• Email: aa2974@cumc.columbia.edu
• Phone: 212-342-0261

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Melatonin plus inhaled nitric oxide for pulmonary hypertension in full-term newborns

  This study tests whether adding melatonin to inhaled nitric oxide helps treat pulmonary hypertension in full-term neonates.

  Recruiting Ain Shams University · Cairo, Abbassia · NCT07850934

• FETO with a Goldballoon device for fetuses with diaphragmatic hernia

  This study tests whether performing Fetoscopic Endoluminal Tracheal Occlusion on pregnancies with fetal diaphragmatic hernia improves baby survival and reduces long-term problems.

  Recruiting University of Michigan · Ann Arbor, Michigan · NCT07577414

• Fetal tracheal occlusion (FETO) for severe congenital diaphragmatic hernia

  This trial will test whether fetal endoluminal tracheal occlusion (FETO) helps fetuses with severe congenital diaphragmatic hernia and intrathoracic liver herniation survive to hospital discharge.

  Recruiting Phase 3 Children's Hospital Medical Center, Cincinnati · Cincinnati, Ohio · NCT07187206

• Long-term outcomes after FETO for severe left or right congenital diaphragmatic hernia

  This trial will test whether performing FETO in fetuses with isolated severe left or right CDH helps more babies survive to hospital discharge and have fewer long-term problems than standard care.

  Recruiting Johns Hopkins University · Baltimore, Maryland · NCT07166172

• Fetal treatment for congenital diaphragmatic hernia

  This study is testing a new way to treat congenital diaphragmatic hernia in unborn babies by placing a balloon in their airway to help their lungs grow before they are born.

  Recruiting Children's Hospital of Philadelphia · Philadelphia, Pennsylvania · NCT06884423

• Fetoscopic balloon (FETO) for severe left and right congenital diaphragmatic hernia — long-term outcomes

  This trial will try placing and later removing a tiny balloon in the fetal windpipe around 27–29 weeks to help babies with severe congenital diaphragmatic hernia and liver herniation survive the newborn period.

  Recruiting The University of Texas Health Science Center, Houston · Houston, Texas · NCT06739356

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.