RECRUITING

Fetoscopic Endoluminal Tracheal Occlusion

Description

The purpose of this research study is to see if the FETO surgery and FETO release (surgery to remove the device) works and is safe for babies with severe right or left Congenital Diaphragmatic Hernia (CDH). CDH is a condition in which a hole in the baby's diaphragm allows the abdominal organs to move into the chest and limit lung growth. The goal of the FETO device is to block the airway with a balloon-type device, allowing fluid to build up and help the unborn baby's lungs grow. Bigger lungs may improve the baby's quality of life.

Study Overview

Study Details

Study overview

The purpose of this research study is to see if the FETO surgery and FETO release (surgery to remove the device) works and is safe for babies with severe right or left Congenital Diaphragmatic Hernia (CDH). CDH is a condition in which a hole in the baby's diaphragm allows the abdominal organs to move into the chest and limit lung growth. The goal of the FETO device is to block the airway with a balloon-type device, allowing fluid to build up and help the unborn baby's lungs grow. Bigger lungs may improve the baby's quality of life.

Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Right and Left Congenital Diaphragmatic Hernia (CDH)

Fetoscopic Endoluminal Tracheal Occlusion

Condition
Congenital Diaphragmatic Hernia
Intervention / Treatment

-

Contacts and Locations

Aurora

Children's Hospital Colorado, Aurora, Colorado, United States, 80045

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Pregnant women age 18 years and older, who are able to consent
  • * Singleton pregnancy
  • * 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%
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Colorado, Denver,

Study Record Dates

2030-03