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

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