Back to resultsA Pilot Study to Evaluate Patient Tolerance and Nursing Ease-of-Use of a Novel Hearing Protection Device (NEATCAP)
Primary Purpose
Hearing Impairment
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NEATCAP
Sponsored by
About this trial
This is an interventional other trial for Hearing Impairment
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
Sites / Locations
- Magee Womens, UPMC Hamot
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Neonates
Arm Description
Neonates admitted to the NICU will be fitted for NEATCAP, non-invasive novel hearing protection device.
Outcomes
Primary Outcome Measures
Number of Participants With Skin Erythema After Device Application
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
Number of Participants With Specific Responses to the Ease of Use Questionnaire for NICU Staff.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02744066
Brief Title
A Pilot Study to Evaluate Patient Tolerance and Nursing Ease-of-Use of a Novel Hearing Protection Device
Acronym
NEATCAP
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
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 31, 2017 (Actual)
Primary Completion Date
October 5, 2017 (Actual)
Study Completion Date
October 5, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael Balsan, MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Impairment
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neonates
Arm Type
Other
Arm Description
Neonates admitted to the NICU will be fitted for NEATCAP, non-invasive novel hearing protection device.
Intervention Type
Device
Intervention Name(s)
NEATCAP
Intervention Description
Neonates will be sized and fitted to wear the non-invasive novel hearing protection device over a set period of time in the NICU. Vitals will be monitored.
Primary Outcome Measure Information:
Title
Number of Participants With Skin Erythema After Device Application
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Number of Participants With Specific Responses to the Ease of Use Questionnaire for NICU Staff.
Description
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.
Time Frame
After 1 hour in phase #1 / After 3 x 8 hours in phase #2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Hours
Maximum Age & Unit of Time
2 Weeks
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Balsan, MD
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Magee Womens, UPMC Hamot
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
15607
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33857731
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.
Results Reference
derived
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A Pilot Study to Evaluate Patient Tolerance and Nursing Ease-of-Use of a Novel Hearing Protection Device
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