Fetoscopic procedure to treat severe congenital diaphragmatic hernia
Study of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Fetuses With Severe Left Congenital Diaphragmatic Hernia (CDH)
This study is testing a special procedure to see if blocking the airway in fetuses with severe congenital diaphragmatic hernia can help their lungs grow better and improve their chances of survival after birth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT02710968 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in treating severe congenital diaphragmatic hernia (CDH) in fetuses. Participants will undergo comprehensive fetal evaluations to confirm eligibility, followed by the FETO procedure, which involves occluding the fetal airway to promote lung development. The procedure is performed between specific gestational ages based on the severity of the condition, and participants will be closely monitored postoperatively. The aim is to improve lung function and survival rates for affected infants.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 and older with a singleton pregnancy and a fetus diagnosed with severe left-sided congenital diaphragmatic hernia.
Not a fit: Patients with right-sided or bilateral diaphragmatic hernias, major associated anomalies, or those with severe maternal medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and lung function in infants with severe congenital diaphragmatic hernia.
How similar studies have performed: Other studies have shown promising results with similar fetoscopic interventions for congenital diaphragmatic hernia, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women age 18 years and older, who are able to consent. * Singleton pregnancy. * Anatomically and chromosomally normal fetus. * Left sided diaphragmatic hernia with liver up. * SEVERE pulmonary hypoplasia with O/E LHR \< 30%. * In patients with O/E LHR 25% to \<30%, enrollment prior to gestational age 30 weeks+0 days to 31 weeks+6 days. * In patients with O/E LHR \<25%, enrollment prior to gestational age 27 weeks+0 days to 29 weeks+6 days. Exclusion Criteria: * Pregnant women \< 18 years. * Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy. * Technical limitations precluding fetoscopic surgery. * Women with history of natural rubber latex allergy. * Preterm labor, cervix shortened \<15 mm within 24 hours prior to the FETO balloon insertion or uterine anomaly strongly predisposing to preterm labor, placenta previa. * Diaphragmatic hernia: right-sided or bilateral, major associated anomalies, isolated left-sided with the O/E LHR ≥ 30%.
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Center for Fetal Therapy — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Ahmet A Baschat, MD — Johns Hopkins University
- Study coordinator: Ahmet A Baschat, MD
- Email: abascha1@JHMI.edu
- Phone: 443 287 9549
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.