100
Participants
Start Date
September 8, 2023
Primary Completion Date
March 8, 2031
Study Completion Date
September 8, 2036
NEOX Cord 1K applied fetoscopically
Under general anesthesia and tocolysis, in-utero repair begins with a laparotomy that is followed by exteriorization of the uterus. The fetus is then positioned by external cephalic version. Uterine entry will be accessed using 3 cannulas, followed by heated-humidified carbon dioxide insufflation for visualization. Then, fetoscopically the placode will be examined and dissected. The lesion will be repaired using NEOX Cord 1K® (HUC) for closure of the first layer over the neural placode. Primary closure of the skin will then occur, or NEOX Cord 1K® (human umbilical cord) will be used for skin closure at the discretion of the Pediatric Neurosurgeon. Finally, the laparotomy site will be sutured in multiple layers.
RECRUITING
The University of Texas Health Science Center at Houston, Houston
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
The University of Texas Health Science Center, Houston
OTHER