Fetal tracheal occlusion to improve lung development in fetuses with severe congenital diaphragmatic hernia
A Prospective Study on the Role of Fetal Endotracheal Occlusion (FETO) in the Resolution of Pulmonary Hypertension Among Fetuses With Severe Congenital Diaphragmatic Hernia
NA · Baylor College of Medicine · NCT03980717
This study is testing whether a procedure that temporarily blocks the trachea of fetuses with severe congenital diaphragmatic hernia can help their lungs develop better and improve their chances of survival at birth.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Baylor College of Medicine (other) |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT03980717 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 to 45 carrying a singleton fetus diagnosed with severe CDH between 28 and 31 weeks of gestation.
Not a fit: Patients with contraindications to abdominal surgery or those whose fetuses have additional severe anomalies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve lung development and survival rates for infants born with severe congenital diaphragmatic hernia.
How similar studies have performed: Previous studies have shown that fetal tracheal occlusion can improve outcomes in similar cases, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Houston, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Congenital Diaphragmatic Hernia, Fetal Tracheal Occlusion, FETO plug-unplug, Goldvalve balloon, Severe Congenital Diaphragmatic Hernia, Goldbal balloon, FETO