A pilot study to assess the safety, efficacy and ease of use of a novel hearing protection device for hospitalized neonates

Abstract

Background: Loud noises in the neonatal intensive care unit (NICU) exacerbate patient cardiac and respiratory activity, disrupt sleep, and may contribute to hearing deficits, speech and language disorders, and neurodevelopmental delays among NICU graduates.

Aims: This study evaluated infant-patient tolerance and nurse ease of use of a novel frequency-selective hearing protection device, DREAMIES (NEATCap Medical, LLC).

Study design and subjects: Fifty neonates receiving care in a Level III NICU participated in a 2-phase prospective study. In Phase 1, 25 infants (mean 36.6 wks GA) wore DREAMIES for two consecutive 30-min periods. In Phase 2, 25 infants (mean 34.8 wks GA) wore DREAMIES between care and feeding times during an 8-h Device-On period followed by an 8-h Device-Off period for three consecutive days.

Outcome measures: Subject tolerance was defined by device-related skin irritation, vital sign measurements, and behavioral state. Device fit and ease of use were also evaluated by NICU nurses.

Results: No skin breakdown was reported in any infant in either phase. Only transient skin erythema was observed. Periods when infants wore DREAMIES resulted in lower heart and respiratory rates and increased sleep (P < 0.001). Nurses reported little to no difficulty in applying or removing the device.

Conclusion: Findings suggest DREAMIES are a safe, easy to use, and effective device that reduces exposure to NICU noise, and may improve cardio-respiratory activity and promote sleep among neonatal patients. Further studies are warranted to examine longer term use and potential benefits of DREAMIES for improving outcomes in infants receiving NICU care. This trial is registered on clinicaltrials.govNCT02744066.

Keywords: Infant developmental; Infant sleep; NICU; Noise reduction; Nursing; Premature infant.

Conflict of interest statement

Declaration of Interest:

Fred Kimock, PhD, and Andrew Unger, MD, have a financial interest in NEATCap Medical, LLC, the developer and manufacturer of the study device. Dr. Balsan, Ms. Burns, Ms. Hirsch, and Dr. Bloch-Salisbury were supported in part by NIH funding and otherwise have no other conflict of interest. Dr.Telesco declares no conflict of interest.

Copyright © 2021. Published by Elsevier B.V.

Figures

Figure 1.

Photo of the DREAMIES device on preterm infant doll model.

Figure 2.

Sound attenuation of DREAMIES device. White bars with solid SD = DREAMIES device; Shaded bars with dotted SD = adapted from animal model [23]). Note, sound filtering of the DREAMIES is similar to that of the sheep gravid uterus (commonly used animal model of maternal-fetal interactions, adapted from Gerhardt [23]). DREAMIES preferentially block high-frequency sounds (e.g., bedside monitor alarms [22]) and allows transmission of some low-frequency sounds (e.g., human voice [38]) as observed in womb during gestation.[23,24].

Figure 3.

Phase 2 study protocol: Data recording times during DEV2-ON and DEV2-OFF periods. Thick black arrows denote the start of nursing cares (every 3 hours). Thin arrows indicate hourly vital signs and sleep assessments. Dark gray regions on the 24-hour timeline indicate when the device was in place on the baby. White regions on the 24-hour timeline indicate when the device was not on the baby. Boxes with 1 2 3 enclosed with solid line indicate the 3-hour periods when DREAMIES was on the infant between nursing cares (DEV2-ON). Boxes with 1 2 3 enclosed with a dotted line indicate 3-hour periods when DREAMIES was not on the infant between nursing cares (DEV2-OFF).

Figure 4.

The nursing fit and ease of use survey.

Figure 5.

Increased sleep and decreased wake with DEV2-ON compared to DEV2-OFF. Closed bar = DEV2-ON (hours 3 and 6); Open bar = DEV2-OFF (hours 12 and 15).