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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• Pregnant women age 18 years and older, who are able to consent

• Singleton pregnancy

• Fetal:

• Normal Karyotype or chromosomal microarray with non-pathologic variants

• Diagnosis of Isolated Left CDH with liver up

• Gestation at enrollment prior to 29 weeks plus 5 days

• SEVERE pulmonary hypoplasia with Ultrasound Observed/Expected Lung-to-Head Ratio (O/E LHR) \< 25%

Locations
United States
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Contact Information
Primary
Holly L Hedrick, MD
hedrick@chop.edu
1-800-468-8376
Backup
Sabrina J Flohr, MPH
flohrs@chop.edu
Time Frame
Start Date: 2015-07
Estimated Completion Date: 2026-02
Participants
Target number of participants: 25
Treatments
Experimental: FETO in CDH
Fetoscopic Endoluminal Tracheal Occlusion (FETO) will be performed by placing a detachable balloon inside the fetal airway and removing the balloon after several weeks. Devices: GoldBAL2 Detachable Balloon and BALTACCIBDPE100 Delivery Catheter
Sponsors
Leads: Children's Hospital of Philadelphia

This content was sourced from clinicaltrials.gov