Fetal treatment 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 pilot trial evaluates the feasibility and safety of Fetal Endoscopic Tracheal Occlusion (FETO) using the Goldballoon Detachable Balloon at UC Davis Medical Center. Pregnant women with severe congenital diaphragmatic hernia (CDH) will undergo the procedure between 27 and 29 weeks of gestation. The study aims to monitor the outcomes and safety of this intervention, requiring participants to attend weekly follow-up appointments until delivery. The trial focuses on a specific patient population with severe pulmonary hypoplasia associated with CDH.

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
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 UC Davis Medical Center and ability to maintain follow up appointments
   * 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 the UC Davis Medical Center.
   * Willing to comply with restrictions of daily living including inability to exercise, have intercourse, or return to work

Exclusion Criteria:

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

   * Inability to reside within 30 minutes of UC Davis Medical Center 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.
7. Bilateral CDH, unilateral CDH with o/e LHR \> 25% or unilateral CDH with o/e LHR \<25% but liver completely down in abdomen
8. Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome
9. Maternal contraindications to elective fetoscopic surgery
10. Significant placental abnormalities (abruption, chorioangioma, accreta) known at time of enrollment and/or surgery
11. Maternal isoimmunization or neonatal alloimmune thrombocytopenia
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

Where it's running

• UC Davis Medical Center
  Sacramento, California, United States Recruiting

Study contacts

• Study coordinator: Amy Powne, MSN, RN
• Email: fctc@ucdavis.edu
• Phone: 916-717-4690

Similar studies

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

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• FETO with a Goldballoon device for fetuses with diaphragmatic hernia

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

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• 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.

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• Fetal treatment for congenital diaphragmatic hernia

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• 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.