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Completed

NCT Number: NCT02744066

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

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.

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Key information

Conditions

Hearing Impairment Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

12 hour–2 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Magee Womens, UPMC Hamot

Erie, Pennsylvania, 15607, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NEATCAP

Device

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Michael Balsan, MD

Other

Registry information

Official study 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

Acronym: NEATCAP

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 20, 2016
Registry last updated
Nov 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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