Literature DB >> 33857731

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

Michael J Balsan1, Jeanne Burns1, Fred Kimock2, Emily Hirsch1, Andrew Unger2, Richard Telesco1, Elisabeth Bloch-Salisbury3.   

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.
Copyright © 2021. Published by Elsevier B.V.

Entities:  

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

Mesh:

Year:  2021        PMID: 33857731      PMCID: PMC8771502          DOI: 10.1016/j.earlhumdev.2021.105365

Source DB:  PubMed          Journal:  Early Hum Dev        ISSN: 0378-3782            Impact factor:   2.079


  29 in total

Review 1.  The effects of noise on preterm infants in the NICU.

Authors:  Elisha M Wachman; Amir Lahav
Journal:  Arch Dis Child Fetal Neonatal Ed       Date:  2010-06-14       Impact factor: 5.747

2.  Preterm infants' sympathetic arousal and associated behavioral responses to sound stimuli in the neonatal intensive care unit.

Authors:  Arash Salavitabar; Kim Kopenhaver Haidet; Cherie S Adkins; Elizabeth J Susman; Charles Palmer; Hanne Storm
Journal:  Adv Neonatal Care       Date:  2010-06       Impact factor: 1.968

3.  Sound environment of the fetal sheep.

Authors:  K J Gerhardt; R M Abrams; C C Oliver
Journal:  Am J Obstet Gynecol       Date:  1990-01       Impact factor: 8.661

4.  The impact of a noise reduction quality improvement project upon sound levels in the open-unit-design neonatal intensive care unit.

Authors:  W F Liu
Journal:  J Perinatol       Date:  2009-12-10       Impact factor: 2.521

5.  Environmental stimulation of the acutely ill premature infant: physiological effects and nursing implications.

Authors:  A T Catlett; D Holditch-Davis
Journal:  Neonatal Netw       Date:  1990-06

Review 6.  Sound and the developing infant in the NICU: conclusions and recommendations for care.

Authors:  S N Graven
Journal:  J Perinatol       Date:  2000-12       Impact factor: 2.521

7.  Reducing light and sound in the neonatal intensive care unit: an evaluation of patient safety, staff satisfaction and costs.

Authors:  M Walsh-Sukys; A Reitenbach; D Hudson-Barr; P DePompei
Journal:  J Perinatol       Date:  2001-06       Impact factor: 2.521

8.  Relationships between environmental stressors and stress biobehavioral responses of preterm infants in NICU.

Authors:  Niang-Huei Peng; Jean Bachman; Ruth Jenkins; Chao-Huei Chen; Yue-Cune Chang; Yu-Shan Chang; Teh-Ming Wang
Journal:  Adv Neonatal Care       Date:  2013-10       Impact factor: 1.968

9.  Alterations in brain structure and neurodevelopmental outcome in preterm infants hospitalized in different neonatal intensive care unit environments.

Authors:  Roberta G Pineda; Jeff Neil; Donna Dierker; Christopher D Smyser; Michael Wallendorf; Hiroyuki Kidokoro; Lauren C Reynolds; Stephanie Walker; Cynthia Rogers; Amit M Mathur; David C Van Essen; Terrie Inder
Journal:  J Pediatr       Date:  2013-10-17       Impact factor: 4.406

10.  Mapping sources of noise in an intensive care unit.

Authors:  J L Darbyshire; M Müller-Trapet; J Cheer; F M Fazi; J D Young
Journal:  Anaesthesia       Date:  2019-05-07       Impact factor: 6.955

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  1 in total

Review 1.  Prevention of Noise-Induced Hearing Loss Using Investigational Medicines for the Inner Ear: Previous Trial Outcomes Should Inform Future Trial Design.

Authors:  Colleen G Le Prell
Journal:  Antioxid Redox Signal       Date:  2021-10-04       Impact factor: 7.468

  1 in total

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