This month’s Paper of the Month is a study published in The Lancet Group by researchers from KU Leuven, American Hospital of Paris, Université Paris-Saclay, and UCL.
The study explores a smarter way to support fetal surgery for babies with congenital diaphragmatic hernia (CDH) a condition that can prevent the lungs from developing properly.
Paper: Non-invasive removal of the Smart tracheal occlusion device for fetal congenital diaphragmatic hernia: a single-arm, open-label, phase 1 study
Authors: francesca russo | Nicolas Sananès | Alexandra Letourneau | Roland Devlieger | Charles Mégier | Liesbeth Lewi | Van Thi Ngoc Huyn | Michael Aertsen | Grégoire Dumery | Jan Deprest | Alexandra Benachi |
What the research is about
Some babies are diagnosed before birth with 𝐂𝐃𝐇. This means the diaphragm does not close properly, allowing organs from the belly to move into the chest and making it harder for the lungs to grow.
For severe cases, doctors can place a tiny balloon inside the baby’s windpipe before birth. This helps the lungs expand and develop. But the balloon must later be removed or deflated before delivery. This study tested Smart-TO, a balloon designed to deflate when exposed to the magnetic field of an MRI machine, helping avoid the need for a second invasive fetal procedure.
Why this matters
Fetal surgery is extremely delicate. Smart-TO could make one important step less invasive by removing the need for a second intrauterine procedure to reopen the baby’s airway.
What they found
The study enrolled 48 pregnant patients. FETO was attempted in 47, and the Smart-TO device was successfully placed in 46 fetuses. MRI-induced deflation was attempted in 44 cases, with a 100% deflation rate. No serious adverse events were considered related to the Smart-TO device.
What it could mean for the future
This could mark an important step toward fetal surgery that is less invasive, easier to manage, and less burdensome for patients, babies, families, and treatment teams.
What's next
This was a phase 1 study, so further research is needed to better understand long-term safety, reliability, and impact in larger clinical settings.
