This pilot study is testing a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy for babies with severe left-sided congenital diaphragmatic hernia (CDH). CDH is a condition where a hole in the baby's diaphragm allows organs to move into the chest, limiting lung growth. The FETO procedure involves placing a small balloon (Balt Goldbal2) in the baby's airway before birth to help their lungs grow. The balloon is placed before 29 weeks and 6 days of pregnancy and removed by 35 weeks and 6 days. This study aims to see if the procedure is possible and safe, hoping to improve the baby's lung development and survival after birth. We are looking for 10 pregnant women (18 or older) with a single baby diagnosed with severe left-sided CDH (O/E LHR < 25%). Success for this study means successfully placing and removing the balloon.

Study design

This is a single-site pilot study, meaning it's a small initial study at one location. It aims to enroll 10 participants.

What's involved

You would undergo one procedure to place the FETO device before 29 weeks 6 days of pregnancy, and a second procedure to remove it by 35 weeks 6 days.

Compensation

Not stated in the trial record.

Follow-up

After delivery, your baby will receive routine care for CDH in the Children's MN NICU. The study measures successful balloon removal by 35 weeks 6 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.