FETO for Congenital Diaphragmatic Hernia
(CHOP FETO Trial)

Recruiting in Palo Alto (17 mi)

Overseen byHolly L Hedrick, MD, FACS

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Holly L Hedrick, MD

No Placebo Group

Trial Summary

What is the purpose of this trial?Congenital diaphragmatic hernia (CDH) is a birth defect characterized by the development of a hole in the diaphragm, the breathing muscle that separates the chest from the abdomen. As a result, 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 Criteria

This trial is for pregnant women over 18 with a single pregnancy and a fetus diagnosed with severe Congenital Diaphragmatic Hernia (CDH). Eligible participants must be before 29 weeks and 6 days of gestation, have no major health issues or contraindications to surgery, and be able to stay near the hospital. Those with multiple pregnancies, latex allergies, additional fetal anomalies, or other medical conditions that could affect surgery safety are excluded.

Inclusion Criteria

My liver is located in my chest area.

Patient meets psychosocial criteria

Singleton pregnancy

+6 more

Exclusion Criteria

Multi-fetal pregnancy

History of natural rubber latex allergy

Psychosocial ineligibility precluding consent: inability to reside within 30 minutes of CHOP and comply with travel for follow-up, lack of support person available to stay with patient at CHOP

+13 more

Participant Groups

The trial tests FETO (Fetoscopic Endoluminal Tracheal Occlusion) using GoldBAL2 Balloon and BALTACCIBDPE100 Catheter in fetuses with CDH. The procedure aims to promote lung growth by temporarily blocking the trachea in utero. It's designed for cases where the liver has moved into the chest cavity due to diaphragm herniation.

2Treatment groups

Experimental Treatment

Active Control

Group I: FETO in CDHExperimental Treatment1 Intervention

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. Assignment will be non-randomized. 40 maternal/fetal dyads will be enrolled in this arm.

Group II: Expectant Management in CDHActive Control1 Intervention

The control arm includes patients eligible for FETO according to side of defect, O/E LHR, and liver position who undergo expectant management rather than FETO intervention. Assignment will be non-randomized. 40 maternal/fetal dyads will be enrolled in this arm.