Fetal tracheal occlusion to improve lung development in fetuses with 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 clinical trial investigates the use of fetal endotracheal occlusion (FETO) to treat severe congenital diaphragmatic hernia (CDH) in fetuses. The procedure involves temporarily occluding the fetal trachea using a balloon device to promote lung development and potentially improve survival rates at birth. Eligible participants are pregnant women carrying fetuses diagnosed with severe CDH, who will undergo detailed evaluations and counseling before consenting to the procedure. The study aims to clarify the role of FETO in resolving pulmonary hypertension associated with severe CDH.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient is a pregnant woman between 18 and 45 years of age
* Singleton pregnancy
* The fetuses will be 28+0/7 to 31+6/7 weeks of gestational age
* Confirmed diagnosis of severe left- or right-sided CDH of the fetus: Observed/expected total lung volume equal to or less than 0.32 with more than 21% of liver herniated into the hemithorax. (Ideally calculated between 28+0/7 and 31+6/7 weeks' gestation.)
* Normal fetal echocardiogram or echocardiogram with a minor anomaly (such a small VSD) that in the opinion of the pediatric cardiologist will not affect postnatal outcome
* Normal fetal karyotype or microarray
* The mother must be healthy enough to have surgery
* Patient and father of the baby provide signed informed consent that details the maternal and fetal risks involved with the procedure
* Patient willing to remain in Houston for the duration following balloon placement until delivery.

Exclusion Criteria:

* Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia
* Allergy to latex
* Allergy or previous adverse reaction to a study medication specified in this protocol
* Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) in the index pregnancy.
* Fetal aneuploidy, known structural genomic variants, other major fetal anomalies that may impact the fetal/neonatal survival or known syndromic mutation
* Suspicion of major recognized syndrome (e.g. Fryns syndrome) on ultrasound or MRI
* Maternal BMI \>40
* High risk for fetal hemophilia

Where it's running

• Texas Childrens Hospital
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Michael Belfort, MD PhD — Baylor College of Medicine
• Study coordinator: Michael Belfort, MD PhD
• Email: belfort@bcm.edu
• Phone: 832-826-7375

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

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• 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.

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• 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.