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

Michael Balsan, MD

Status: Completed

Conditions: Hearing Impairment

Treatments: Device: NEATCAP

Study type: Interventional

Funder types: Other

Identifiers

NCT02744066

PRO16010220

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 12 hours to 2 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Neonates

Other group

Description:

Neonates admitted to the NICU will be fitted for NEATCAP, non-invasive novel hearing protection device.

Treatment:

Device: NEATCAP