Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2026-03-03 @ 3:00 PM
Study NCT ID:
NCT02744066
Status:
COMPLETED
Last Update Posted:
2018-11-29
First Post:
2016-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Pilot Study to Evaluate Patient Tolerance and Nursing Ease-of-Use of a Novel Hearing Protection Device
Sponsor:
Michael Balsan, MD
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEATCAP
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: