Clinical trial NCT02224859: Invictus Medical, Medical Cranial Support Device (CSD) is a Device Safety Study in Infants at Risk of Head Ulcers.
Official title: Clinical Safety and Utility of the Invictus Cranial Support Device (CSD)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Other Preterm Infants
Lead sponsor: Invictus Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2014-08-25
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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, 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

Eligibility criteria: Inclusion Criteria:

1. Have a parent(s) or guardian(s) who has provided written informed consent for the patient to participate in the study.
2. Be \> 30.0 weeks gestational age at time of enrollment into the study
3. Be in medically stable condition within the NICU
4. Be able to breathe adequately on room air without support
5. Be deemed suitable (i.e., in no acute distress) for participating in the study for approximately six (6) hours, in the investigator's opinion
6. Upon visual inspection have intact skin without breaks and/or lacerations of the scalp or adjacent areas where the CSD will fit

Exclusion Criteria:

1. The use of any additional respiratory support (i.e., intubation, using CPAP, etc.) is required,
2. The patient has any genetic dermatological conditions
3. The patient's head size is not appropriate for the device \< 28 centimeters or \>34.3 centimeters (\< 11 or \> 13.5 inches)
4. 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

Primary outcomes:
measure: HCP assessments of the products form, fit, likely effectiveness, and safety for internal decision making and for support of an FDA 510K submission to demonstrate form and fit as it relates to a predicate device.
timeFrame: Each patient will spend approximately six (6) hours in the study if no adverse experiences
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
Study officials:
affiliation: Baylor Health Care System
name: Mustafa . Suterwala, MD
role: PRINCIPAL_INVESTIGATOR
References: