A Pilot Study to Evaluate Patient Tolerance and Nursing Ease-of-Use of a Novel Hearing Protection Device

Study Overview
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Brief Summary
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Before they are born, babies are protected from hearing very loud noises by their mother's bodies. After delivery, they are exposed to many loud noises that are potentially harmful. These noises happen in the neonatal intensive care unit (NICU). The purpose of this research project is to test the fit and the ease-of-use of a new device that may protect infant's hearing in the NICU.

Detailed Description
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Despite the best efforts of Neonatal Intensive Care Unit (NICU) caregivers, vulnerable and fragile NICU patients are frequently exposed to noxious levels of noise from monitoring and respiratory equipment alarms, as well as from routine NICU care practices. Particularly detrimental to sleep and auditory development are patient exposures to high frequency noises that are specifically designed to alert NICU caregivers to important changes in patient status. This pilot study will help evaluate the fit, ergonomic design and the ease-of-use of a novel hearing protection system (special ear-muffs along with a unique attachment mechanism) specifically designed top diminish the transmission of high frequency noises to patients within the NICU, while allowing some transmission of low frequency sounds, such as a mother's voice.

Official Title
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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

Conditions
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Hearing Impairment

Intervention / Treatment
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* Device: NEATCAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Neonate admitted to the Neonatal Intensive Care Unit Age greater than 12 hours and less than 2 weeks Informed consent from the parent(s) Exclusion Criteria: Significant cranial trauma noted on admission Congenital anomalies of the head and/or neck Hemodynamic instability requiring pharmacologic intervention Recommendation by the attending neonatologist not to enroll the patient

Ages Eligible for Study
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Minimum Age: 12 Hours
Maximum Age: 2 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Neonates<br>Neonates admitted to the NICU will be fitted for NEATCAP, non-invasive novel hearing protection device. | Device: NEATCAP<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Skin Erythema After Device Application | 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. | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Specific Responses to the Ease of Use Questionnaire for NICU Staff. | 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. | After 1 hour in phase #1 / After 3 x 8 hours in phase #2 |