Status:
WITHDRAWN
Invictus Medical, Medical Cranial Support Device (CSD) is a Device Safety Study in Infants at Risk of Head Ulcers.
Lead Sponsor:
Invictus Medical, Inc.
Conditions:
Other Preterm Infants
Eligibility:
All Genders
30-36 years
Phase:
NA
Brief Summary
While using the device as a cushion, the passive distribution of pressure over bony skull prominences of infants will protect against formation of pressure ulcers.
Detailed Description
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...
Eligibility Criteria
Inclusion
- Have a parent(s) or guardian(s) who has provided written informed consent for the patient to participate in the study.
- Be \> 30.0 weeks gestational age at time of enrollment into the study
- Be in medically stable condition within the NICU
- Be able to breathe adequately on room air without support
- Be deemed suitable (i.e., in no acute distress) for participating in the study for approximately six (6) hours, in the investigator's opinion
- Upon visual inspection have intact skin without breaks and/or lacerations of the scalp or adjacent areas where the CSD will fit
Exclusion
- The use of any additional respiratory support (i.e., intubation, using CPAP, etc.) is required,
- The patient has any genetic dermatological conditions
- The patient's head size is not appropriate for the device \< 28 centimeters or \>34.3 centimeters (\< 11 or \> 13.5 inches)
- Patient has significant medical condition(s) (e.g., encephalocele, IVH, Shunt, etc.) that makes participating in the study not in the patient's best interest
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02224859
Start Date
March 1 2014
End Date
January 1 2015
Last Update
March 24 2015
Active Locations (1)
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1
Baylor University Medical Center
Dallas, Texas, United States, 75246