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

NCT02744066 | Completed Results FDA Device

• 1 other identifier: PRO16010220
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Impairment

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (1)

• Number of Participants With Specific Responses to the Ease of Use Questionnaire for NICU Staff.

  After 1 hour in phase #1 / After 3 x 8 hours in phase #2

Study Arms (1)

Neonates

OTHER

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

Device: NEATCAP

Interventions

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.

Neonates

Eligibility Criteria

• Age: 12 Hours - 2 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonate admitted to the Neonatal Intensive Care Unit
• Age greater than 12 hours and less than 2 weeks
• Informed consent from the parent(s)

You may not qualify if:

• 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

Sponsors & Collaborators

• Michael Balsan, MD: lead

Study Sites (1)

Magee Womens, UPMC Hamot

Erie, Pennsylvania, 15607, United States

Location

Related Publications (1)

• 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.

  PMID: 33857731 DERIVED

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Limited number of very low birth weight infants in the available study population.

Results Point of Contact

• Title: Dr. Michael J. Balsan
• Organization: Magee Womens, UPMC Hamot Hospital

balsanmj@upmc.edu

814-877-3190

Study Officials

• Michael J Balsan, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: April 20, 2016
• Study Start: January 31, 2017
• Primary Completion: October 5, 2017
• Study Completion: October 5, 2017
• Last Updated: November 29, 2018
• Results First Posted: November 29, 2018

Record last verified: 2018-11

Locations

US (1)