Clinical trial NCT02744066: A Pilot Study to Evaluate Patient Tolerance and Nursing Ease-of-Use of a Novel Hearing Protection Device
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Impairment
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 55
Sex: ALL
Minimum age (years): 12
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Skin Erythema After Device Application
timeFrame: 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 outcomes:
measure: Number of Participants With Specific Responses to the Ease of Use Questionnaire for NICU Staff.
timeFrame: After 1 hour in phase #1 / After 3 x 8 hours in phase #2
Other outcomes:
Locations:
city: Erie
country: United States
facility: Magee Womens, UPMC Hamot
state: Pennsylvania
Study officials:
affiliation: Principal Investigator
name: Michael J Balsan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Balsan MJ, Burns J, Kimock F, Hirsch E, Unger A, Telesco R, Bloch-Salisbury E. A pilot study to assess the safety, efficacy and ease of use of a novel hearing protection device for hospitalized neonates. Early Hum Dev. 2021 May;156:105365. doi: 10.1016/j.earlhumdev.2021.105365. Epub 2021 Mar 26.