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

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ClinicalTrials.gov Identifier: NCT02744066
Recruitment Status : Completed
First Posted : April 20, 2016
Results First Posted : November 29, 2018
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Balsan, MD, University of Pittsburgh

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hearing Impairment Device: NEATCAP Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : January 31, 2017
Actual Primary Completion Date : October 5, 2017
Actual Study Completion Date : October 5, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Noise

Arms and Interventions
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Arm Intervention/treatment
Neonates
Neonates admitted to the NICU will be fitted for NEATCAP, non-invasive novel hearing protection device.
 Device: NEATCAP
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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Skin Erythema After Device Application [ 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. ]
    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 :
  1. Number of Participants With Specific Responses to the Ease of Use Questionnaire for NICU Staff. [ Time Frame: After 1 hour in phase #1 / After 3 x 8 hours in phase #2 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   up to 2 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02744066


Locations
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United States, Pennsylvania
Magee Womens, UPMC Hamot
Erie, Pennsylvania, United States, 15607
Sponsors and Collaborators
Michael Balsan, MD
Investigators
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Principal Investigator: Michael J Balsan, MD Principal Investigator
  Study Documents (Full-Text)

Documents provided by Michael Balsan, MD, University of Pittsburgh:
Study Protocol and Statistical Analysis Plan  [PDF] April 28, 2016

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Michael Balsan, MD, Associate Professor of Pediatrics, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02744066    
Other Study ID Numbers: PRO16010220
First Posted: April 20, 2016    Key Record Dates
Results First Posted: November 29, 2018
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
 Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases