Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO)

Description

The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore adequate lung growth for neonatal survival.

Conditions

Congenital Diaphragmatic Hernias

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Study Overview

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Study Details

Study overview

The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore adequate lung growth for neonatal survival.

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

Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO)

Condition
Congenital Diaphragmatic Hernias
Intervention / Treatment

-

Contacts and Locations

Dallas

Medical City Children's Hospital, Dallas, Texas, United States, 75230

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 CDH with liver up
  • * Gestation at enrollment prior to 29 wks plus 6 days
  • * SEVERE pulmonary hypoplasia with Ultra Sound O/E LHR \< 25%
  • * 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
  • * Diaphragmatic hernia: right-sided or bilateral, major associated anomalies, isolated left-sided with the O/E LHR ≥ 25%
  • * 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

Connecticut Children's Medical Center,

Timothy Crombleholme, MD, PRINCIPAL_INVESTIGATOR, Medical City Children's Hospital

Study Record Dates

2030-08