A Pilot Study to Evaluate Patient Tolerance and Nursing Ease-of-Use of a Novel Hearing Protection Device (NEATCAP)
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|ClinicalTrials.gov Identifier: NCT02744066|
Recruitment Status : Completed
First Posted : April 20, 2016
Results First Posted : November 29, 2018
Last Update Posted : November 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hearing Impairment||Device: NEATCAP||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study to Evaluate Patient Tolerance and Nursing Ease-of-Use of a Novel Hearing Protection Device to Reduce Exposure to Excessive Noise Among Patients Undergoing Neonatal Intensive Care|
|Actual Study Start Date :||January 31, 2017|
|Actual Primary Completion Date :||October 5, 2017|
|Actual Study Completion Date :||October 5, 2017|
Neonates admitted to the NICU will be fitted for NEATCAP, non-invasive novel hearing protection device.
Neonates will be sized and fitted to wear the non-invasive novel hearing protection device over a set period of time in the NICU. Vitals will be monitored.
- Number of Participants With Skin Erythema After Device Application [ Time Frame: Skin erythema was evaluated at the time of device removal after 1 hour of application in phase #1 and after 3 daily 8 hour periods of application in phase #2. ]Skin will be assessed for adverse effects such as any device-related adverse events, including evidence of skin redness, rash and/or bruising or discomfort at the site of device application. Skin erythema was described as none, mild, moderate or severe as evaluated by the NICU nursing staff.
- Number of Participants With Specific Responses to the Ease of Use Questionnaire for NICU Staff. [ Time Frame: After 1 hour in phase #1 / After 3 x 8 hours in phase #2 ]A >80% positive response to a multi-question Ease-of-Use Questionnaire completed by the participating NICU staff. Ease-of-Use Questionnaire constructed on a 5 point Likert Scale: 1 = Strongly Disagree, 2 = Disagree, 3 = Neutral, 4 = Agree, 5 = Strongly Agree that the device was easy-to-use. Phase #1 consists of 25 data points. Phase #2 consists of 25 data points. Evaluations were obtained after device removal in both phases.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02744066
|United States, Pennsylvania|
|Magee Womens, UPMC Hamot|
|Erie, Pennsylvania, United States, 15607|
|Principal Investigator:||Michael J Balsan, MD||Principal Investigator|