Fetal treatment for 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 evaluates the safety and efficacy of fetoscopic endoluminal tracheal occlusion (FETO) in treating congenital diaphragmatic hernia (CDH) in fetuses. Pregnant women with eligible singleton pregnancies will undergo a series of prenatal evaluations to determine candidacy for the intervention. If eligible, a balloon will be placed in the fetal airway to block it, allowing the lungs to grow before delivery. Participants will be closely monitored throughout the process at the Children's Hospital of Philadelphia.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Pregnant women age 18 years and older
2. Singleton pregnancy
3. Normal fetal karyotype with confirmation by culture results, whole exome sequencing (WES), whole genome sequencing (WGS), or chromosomal microarray with non-pathologic variants. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is greater than 26 weeks.
4. Gestational age at enrollment is prior to 29 weeks 6 days
5. Liver is intrathoracic
6. Isolated left congenital diaphragmatic hernia (CDH) with observed/expected lung to head ratio (O/E LHR) of less than 30% at enrollment (18\^0 to 29\^5 weeks), or:
7. Isolated right CDH with O/E LHR equal to or less than 45% at enrollment (18\^0 to 29\^5 weeks).
8. Cervical length by transvaginal ultrasound equal to or greater than 20 mm within 24 hours of fetoscopic endoluminal tracheal occlusion (FETO) procedure
9. Patient meets psychosocial criteria
10. Informed consent

Exclusion Criteria:

1. Patient is less than 18 years of age
2. Multi-fetal pregnancy
3. History of natural rubber latex allergy
4. Preterm labor, cervix shortened (less than 20 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa
5. Psychosocial ineligibility, precluding consent:

   * Inability to reside within 30 minutes of the Children's Hospital of Philadelphia (CHOP) and inability to comply with the travel for the follow-up requirements of the trial
   * Patient does not have a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at CHOP
6. Bilateral CDH, isolated left sided CDH with O/E LHR greater than or equal to 30% (measured at 18\^0 to 29\^5 weeks), isolated right sided CDH with O/E LHR greater than 45% (measured at 180 to 295 weeks), as determined by ultrasound
7. No Liver herniation into thoracic cavity.
8. Additional fetal anomaly by ultrasound, magnetic resonance imaging (MRI), or echocardiogram at the fetal treatment center. Exclude chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (ie. CDH and congenital heart disease) or presence of an underlying genetic syndrome (ie. Fryns).
9. Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
10. History of incompetent cervix with or without cerclage
11. Placental abnormalities (previa, abruption, accrete) known at time of enrollment.
12. Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy.
13. 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.
14. Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality
15. There is no safe or technically feasible fetoscopic approach to balloon placement.
16. Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy.

Where it's running

• Children's Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Holly L Hedrick, MD, FACS — Children's Hospital of Philadelphia
• Study coordinator: Holly L Hedrick, MD, FACS
• Email: hedrick@chop.edu
• Phone: 1-800-468-8376

Similar studies

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

• 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

• Fetoscopic tracheal balloon occlusion for severe left congenital diaphragmatic hernia

  This research will try placing a temporary balloon in the fetal windpipe to help lungs grow in pregnancies where the baby has a severe left congenital diaphragmatic hernia.

  Recruiting University of Miami · Miami, Florida and 1 other locations · NCT03138863

• Fetal tracheal occlusion for severe congenital diaphragmatic hernia

  This study is testing if a procedure called fetal tracheal occlusion can help improve lung development in unborn babies with severe congenital diaphragmatic hernia.

  Recruiting Children's Hospital Medical Center, Cincinnati · Cincinnati, Ohio · NCT02986087

• 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

• 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

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.