Other Preterm Infants Clinical Trial
Official title:
Clinical Safety and Utility of the Invictus Cranial Support Device (CSD)
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.
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. Specifically, this study
will:
- Collect safety information at specified time points (baseline, 15 minutes, 1 hour, 3
hours, and 6 hours) utilizing a widely used dermal assessment tool, health assessments
(temperature, pulse, respiration rate), excessive scalp sweating/moisture accumulation,
and adverse events, as reflected in the Table 1.0, Time and Events Table.
Additional safety assessments will be performed following the final removal of the CSD from
the infants head. Refer to Table 1.0 Time and Events Table and section 6.1.
- Assess the HCP's impression of likely safety and effectiveness (Function Assessments)
of the CSD based on experience working with infants in the NICU, Evaluate/Rate the form
and fit, and evaluate/rate the ease of application of the product.
- Collect additional feedback (if any) on HCP's impressions of device design and
usability based on experience working as a HCP in the NICU
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
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