Fetoscopic Endoluminal Tracheal Occlusion in Severe Left Congenital Diaphragmatic Hernia

Description

CDH is a birth defect characterized by the development, very early in gestation, of a hole in the diaphragm, the breathing muscle that separates the chest from the abdomen. As a result, the intestines and other organs in the abdomen can move into the chest and press on the developing lungs. This prevents the lungs from growing and developing normally. In severe cases, CDH can lead to serious disease and death at birth. For these babies, treatment before birth may allow the lungs to grow enough before birth so these children are capable of surviving and thriving.

Conditions

Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia

Study Overview

Study Details

Study overview

CDH is a birth defect characterized by the development, very early in gestation, of a hole in the diaphragm, the breathing muscle that separates the chest from the abdomen. As a result, the intestines and other organs in the abdomen can move into the chest and press on the developing lungs. This prevents the lungs from growing and developing normally. In severe cases, CDH can lead to serious disease and death at birth. For these babies, treatment before birth may allow the lungs to grow enough before birth so these children are capable of surviving and thriving.

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

Fetoscopic Endoluminal Tracheal Occlusion in Severe Left Congenital Diaphragmatic Hernia

Condition
Congenital Diaphragmatic Hernia
Intervention / Treatment

-

Contacts and Locations

Philadelphia

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19104

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

  • 1. Pregnant women age 18 years and older, who are able to consent
  • 2. Singleton pregnancy
  • 3. Normal Karyotype or chromosomal microarray with non-pathologic variants
  • 4. Diagnosis of Isolated Left CDH with liver up
  • 5. Gestation at enrollment prior to 29 weeks plus 5 days
  • 6. SEVERE pulmonary hypoplasia with Ultrasound Observed/Expected Lung-to-Head Ratio (O/E LHR) \< 25%
  • 1. Pregnant women \< 18 years
  • 2. Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
  • 3. Technical limitations precluding fetoscopic surgery
  • 4. Rubber latex allergy
  • 5. 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
  • 6. Psychosocial ineligibility, precluding consent
  • 7. Fetal Diaphragmatic hernia: right-sided or bilateral, major associated anomalies, isolated left-sided with the O/E LHR ≥ 25%
  • 8. Inability to remain at FETO site during time period of tracheal occlusion, delivery and postnatal care

Ages Eligible for Study

18 Years to 50 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Children's Hospital of Philadelphia,

Holly L Hedrick, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia and the Center for Fetal Diagnosis and Treatment

Study Record Dates

2026-02