Invictus Medical, Medical Cranial Support Device (CSD) is a Device Safety Study in Infants at Risk of Head Ulcers.

"There is no active therapeutic treatment (e.g., medication, stimulation, etc.) associated with this device or study. All supplies for this study will be supplied by the sponsor and returned to them upon completion of the trial.~The device used in this study is a soft gel based bonnet referred to as a Cranial Support Device (CSD). In this study, after obtaining written informed consent from the patient's parent(s) or guardian(s) and confirming that the patient meets all inclusion and no exclusion criteria, the study HCP will place the CSD on the selected patient."

This study is designed to evaluate the safety of the Invictus Cranial Support Device (CSD) when worn by medically stable infants within a neonatal intensive care unit (NICU), to evaluate the form, fit, and ease of use/application of the CSD device (i.e., utility), as well as initial impressions of safety, by health care providers (HCPs) after placing the current CSD on infants for approximately six (6) hours in a NICU