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

Not Applicable
Completed
Conditions
Hearing Impairment
Registration Number
NCT02744066
Lead Sponsor
Michael Balsan, MD
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
55
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Number of Participants With Skin Erythema After Device ApplicationSkin 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.

Secondary Outcome Measures
NameTimeMethod
Number of Participants With Specific Responses to the Ease of Use Questionnaire for NICU Staff.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.

Trial Locations

Locations (1)

Magee Womens, UPMC Hamot

🇺🇸

Erie, Pennsylvania, United States

Magee Womens, UPMC Hamot
🇺🇸Erie, Pennsylvania, United States
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