Fetoscopic Endoluminal Tracheal Occlusion

Launched by UNIVERSITY OF COLORADO, DENVER · Sep 13, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a special surgery called Fetoscopic Endoluminal Tracheal Occlusion (FETO) to help babies with a serious condition known as Congenital Diaphragmatic Hernia (CDH). CDH occurs when there is a hole in the diaphragm, which is the muscle that separates the chest from the abdomen. This hole can allow organs from the abdomen to move up into the chest, making it hard for the baby’s lungs to grow properly. The FETO procedure involves placing a small balloon in the baby’s airway to block it. This helps fluid build up in the lungs, which may encourage lung growth and improve the baby's quality of life.

To participate in the trial, pregnant women must be at least 18 years old and have a single baby that has been diagnosed with severe CDH before the 30th week of pregnancy. The baby's condition needs to be serious enough that it could significantly affect lung growth. Women who have certain health issues, are under 18, or have other complications that could pose risks during the surgery are not eligible. If accepted, participants can expect to have the FETO procedure and follow-up care to monitor the baby's health, especially the growth of the lungs. This study is currently active but not recruiting new participants.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Pregnant women age 18 years and older, who are able to consent
• • Singleton pregnancy
• • Fetal
• • Normal Karyotype
• • Fetal Diagnosis of Isolated Left or Right CDH with liver up
• • Gestation at enrollment prior to 29 wks plus 6 days
• • SEVERE pulmonary hypoplasia with Ultra Sound L-sided O/E LHR \< 25% or R-sided O/E LHR \<45%
• Exclusion Criteria:
• • Pregnant women \<18 years of age.
• • Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
• • Technical limitations precluding fetoscopic surgery
• • Rubber latex allergy
• • 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
• • Psychosocial ineligibility, precluding consent
• • Inability to remain at FETO site during time period of tracheal occlusion, delivery and postnatal care