Fetoscopic procedure to treat severe congenital diaphragmatic hernia in unborn babies
Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)
This study is testing a procedure that places a balloon in the airway of unborn babies with severe congenital diaphragmatic hernia to help their lungs grow before they are born.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Children's Hospital of Philadelphia Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT02549820 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on treating severe congenital diaphragmatic hernia (CDH) in fetuses by performing fetoscopic endoluminal tracheal occlusion (FETO). The procedure involves placing a balloon in the unborn baby's airway to block it, allowing the lungs to grow before birth. Eligible pregnant women will undergo a series of evaluations and, if accepted, will have the balloon placed between 27 and 29 weeks of gestation. The balloon will be monitored and removed at a later gestational age, followed by postnatal care and surgery to repair the diaphragm at the Children's Hospital of Philadelphia.
Who should consider this trial
Good fit: Ideal candidates are pregnant women over 18 with a singleton pregnancy diagnosed with isolated left CDH and severe pulmonary hypoplasia.
Not a fit: Patients with right-sided or bilateral diaphragmatic hernias or those with major associated anomalies will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve lung development and survival rates for infants with severe CDH.
How similar studies have performed: Previous studies have shown promise with similar fetoscopic interventions for congenital diaphragmatic hernia, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Pregnant women age 18 years and older, who are able to consent 2. Singleton pregnancy Fetal: 3. Normal Karyotype or chromosomal microarray with non-pathologic variants 4. Diagnosis of Isolated Left CDH with liver up 5. Gestation at enrollment prior to 29 weeks plus 5 days 6. SEVERE pulmonary hypoplasia with Ultrasound Observed/Expected Lung-to-Head Ratio (O/E LHR) \< 25% Exclusion Criteria: 1. Pregnant women \< 18 years 2. Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy 3. Technical limitations precluding fetoscopic surgery 4. Rubber latex allergy 5. Preterm labor, cervix shortened (\<15 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa 6. Psychosocial ineligibility, precluding consent 7. Fetal Diaphragmatic hernia: right-sided or bilateral, major associated anomalies, isolated left-sided with the O/E LHR ≥ 25% 8. Inability to remain at FETO site during time period of tracheal occlusion, delivery and postnatal care
Where this trial is running
Philadelphia, Pennsylvania
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Holly L Hedrick, MD — Children's Hospital of Philadelphia and the Center for Fetal Diagnosis and Treatment
- Study coordinator: Holly L Hedrick, MD
- Email: hedrick@chop.edu
- Phone: 1-800-468-8376
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.