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

Completed · Not applicable

Conditions studied: Hearing Impairment

In brief

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.

Key facts

Study ID

NCT02744066

Run by

Michael Balsan, MD

People needed

55

Starts

2017-01-31

Expected to finish

2017-10-05

Last updated by the study team

2018-11-29

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Magee Womens, UPMC Hamot — Erie, Pennsylvania, United States

Full record on ClinicalTrials.gov

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