Congenital diaphragmatic hernia occurs in approximately 1 in 3000 babies. In these babies, the diaphragm, a muscle that separates the abdomen (belly) from the chest, has a hole that allows intestines (or bowel) and other organs to enter the chest. The presence of these organs in the chest prevents the baby’s lungs from developing. If the problem is not treated, 50-69% of these babies will die after birth. Of those that survive, approximately 50% will need treatment with an artificial lung machine, and have a high risk (67%) of major brain injury. Babies with a right-sided hernia have a lower survival rate that those with a left-sided hernia. Treatment of CDH inside the womb has been performed, but has met with many difficulties. Currently, research is being directed at blocking the airway of the baby rather than treating the hernia itself. Blockage of the airway allows the lungs of the baby to grow such that repair of the hernia can be delayed until the birth of the child. We have conducted animal experiments to test a springy drum-like device that can be placed inside the airway of the baby to block it. Although we have had some success in these experiments, we are just beginning to test this device in humans.

This study is designed to develop a technique to block the airway of the baby using an intraluminal tracheal occluding device, to allow the fetal lungs to develop. The device consists of a fine wire cylinder that shrinks down to a diameter of 2 mm (approximately 1/10th of an inch) and expands itself to a diameter of 6 mm (auto expandable device). Both round ends of the cylinder will be covered with a layer of suture material (mesh) to block the trachea (windpipe).

Potential study results include the following:

a) Improved lung function such that the baby can survive with conventional therapy.
b) Improved lung function such that the baby can survive with ECMO therapy.**
c) No effect on infant’s survival chances or lung development.

** ECMO is an acronym that stands for “extracorporeal membrane oxygenation.” This means that oxygen will be added to the baby’s blood in a machine outside of the body. ECMO therapy is only available for infants reaching a weight of 2.0 – 2.5 kilograms and a gestational age of 33-34 weeks. In situations b & c there may be a benefit to delivering the baby at an ECMO center. Jackson Health System is an ECMO Center. Almost half of all newborn babies who have congenital diaphragmatic hernia will need an artificial lung machine call ECMO.

To participate in this trial you are required to live in Miami or move to and remain in Miami for the remainder of the pregnancy to allow for accurate follow-up ultrasound assessments of the device placement and proper removal of the device at the time of delivery.

INCLUSION CRITERIA:
1) Absence of other major congenital anomalies (e.g., congenital heart disease).
2) Normal karyotype
3) Thin/non-obese complexion (<180 lbs.)
4) Local patient, or patient willing to remain in Miami for the duration of the pregnancy
5) Gestational age at time of diagnosis: less than 25 weeks of gestation
6) Gestational age up to 30 6/7 weeks
7) Any severe congenital diaphragmatic hernia:
8) Right-sided hernia; or
9) Left-sided hernia with relatively small right lung volume (lung-to-head circumference ratio of less than or equal to 0.9); or left-sided hernia with liver herniation into the left hemithorax (“liver-up”)
10) Agree to be delivered by cesarean section.

EXCLUSION CRITERIA:
1) Patients unwilling to participate in the study or to be managed by our group here in Miami
2) Presence of major congenital anomalies
3) Abnormal karyotype
4) Ruptured membranes
5) Chorioamnionitis
6) Diagnosis made after 25 weeks gestation and (except for right-sided CDH) a right lung area to head circumference ratio greater than 0.9