Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Severe Left Diaphragmatic Hernia (CDH)

Launched by JOHNS HOPKINS UNIVERSITY · Mar 16, 2016

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called fetoscopic endoluminal tracheal occlusion (FETO) for babies diagnosed with severe congenital diaphragmatic hernia (CDH). CDH is a condition where there is a hole in the diaphragm, which can affect the development of the lungs. The goal of this trial is to see if performing FETO can help improve survival rates and reduce complications for babies with this serious condition, especially those identified as having the most severe cases before they are born.

To participate in the trial, pregnant women must be at least 18 years old and have a single baby with a left-sided diaphragmatic hernia. The baby must also show signs of severe lung underdevelopment, as determined by specific measurements taken during ultrasound. Participants will have the FETO procedure performed under supervision, which involves placing a balloon in the baby's trachea to help the lungs grow better. If you or someone you know is expecting and meets these criteria, this trial could offer a potential new option for treating severe CDH.

Gender

FEMALE

Eligibility 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%.