CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 55 enrolled
Drug / intervention
NEATCAPdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02744066
NCT02744066N/ACompleted
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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

Michael Balsan, MD·interventional·Posted Apr 20, 2016·Updated Nov 29, 2018

In Brief

A clinical study evaluating NEATCAP for Hearing Impairment. Completed, enrolled 55 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHearing Impairment
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedApr 20, 2016
Enrollment StartJan 31, 2017
Primary CompletionOct 5, 2017
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 10.2 years ago

Interventions

NEATCAPdevice

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.