A Pilot Study to Evaluate Patient Tolerance and Nursing Ease-of-Use of a Novel Hearing Protection Device
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 12/1/2018 |
| Start Date: | January 31, 2017 |
| End Date: | October 5, 2017 |
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
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.
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.
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.
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.
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
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