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 study investigates the efficacy of fetal endoscopic tracheal occlusion (FETO) in treating severe congenital diaphragmatic hernia (CDH). It involves the insertion of a balloon into the fetal trachea to improve lung development and function. The study will collect data on the safety and effectiveness of the off-label use of the FETO Goldballoon, manufactured by Balt medical, in a specialized medical center with advanced maternal-fetal medicine and neonatal services. The goal is to assess the risks and benefits of this intervention for affected fetuses.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Maternal Age: 18-50
* Singleton gestation
* Gestational age before 29 weeks 6 days
* 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.
* Normal genetic karyotype or microarray testing by amniocentesis or chorionic villus sampling (CVS)
* Absence of associated fetal structural cardiac anomalies by a dedicated fetal echocardiogram
* Absence of other structural anomalies by ultrasound or MRI
* Appropriate multi-disciplinary counseling performed with maternal-fetal medicine, neonatology, pediatric surgery, genetics, pediatric otolaryngology (ENT).
* Must be willing to remain near LPCH Stanford (within 30 minutes from the hospital) for the duration of the balloon placement.
* 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.
* Planned pregnancy surveillance at LPCH Stanford
* Planned delivery at LPCH Stanford
* Able to provide written consent
* Willingness to comply with all study procedures and availability (meets psychosocial criteria) for the duration of the study including having a support person

Exclusion Criteria:

* Contraindications to fetal surgery including poorly controlled hypertension, diabetes or other maternal medical condition including hematological disorder
* 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)
* Non-isolated CDH - CDH with additional structural anomalies
* 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
* History of natural rubber latex allergy
* Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality
* Participation in another intervention study that influences maternal and fetal morbidity and mortality.
* 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
* Right-sided CDH O/E LHR \>30% or right-sided CDH with O/E LHR \<30% with liver completely down in abdomen
* Significant placental abnormalities (abruption, chorioangioma, accreta) known at the time of enrollment and/or surgery
* Maternal-fetal Rhesus 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
* No safe or feasible fetoscopic approach to balloon placement.

Where it's running

• Lucile Packard Children's Hospital
  Stanford, California, United States Recruiting

Study contacts

• Principal investigator: Yair Blumenfeld, MD — Stanford University

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

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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

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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.

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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.