Fetoscopic procedure for severe congenital diaphragmatic hernia in fetuses

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 investigates the feasibility of Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy for fetuses diagnosed with severe congenital diaphragmatic hernia (CDH). The procedure involves inserting a detachable balloon into the fetal trachea to increase lung volume before birth, potentially improving survival rates after delivery. The trial will enroll 10 pregnant women who meet specific criteria and will monitor their health and the health of their children until the children are two years old. Participants will be required to reside within 30 minutes of the hospital during the study period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Provision of signed and dated informed consent form
* Pregnant individuals age 18 years and older
* Singleton pregnancy
* 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
* Isolated left 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) OR Isolated right CDH with severe pulmonary hypoplasia with o/e LHR \</=35% with liver up (measured at 18 weeks 0 days to 29 weeks 5 days of gestation)
* Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days as determined by clinical information and evaluation of first ultrasound
* Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects
* Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study

  * 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
  * 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
  * Willingness to comply with study restrictions on work, exercise, and intercourse
* Meets psychosocial criteria

Exclusion Criteria:

* Rubber latex allergy
* 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
* 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
* Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
* History of incompetent cervix with or without cerclage
* Placental abnormalities (previa, abruption, accreta, chorioangioma) known at time of enrollment
* Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
* 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
* Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality
* There is no safe or technically feasible fetoscopic approach to balloon placement
* Participation in another intervention study that influences maternal and fetal morbidity and mortality
* Any other condition which, in the opinion of the investigator, would compromise safety, feasibility or impede compliance

Where it's running

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

Study contacts

• Principal investigator: Aimen Shaaban, MD — Ann & Robert H Lurie Children's Hospital of Chicago
• Study coordinator: Aimen Shaaban, MD
• Email: AShaaban@luriechildrens.org
• Phone: 312-227-4747

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.