White Noises and Parental Voices Against Noises Damage in Preterm Babies: a Randomised Trial’s Protocol
Published 2025-03-31
Keywords
- Nursing Care,
- Parents,
- Randomized Controlled Trial,
- Preterm,
- Noise
- Voice ...More
Copyright (c) 2025 Silvia Rossi, Simona Serveli, Ilaria Artuso, Stefano Parodi, Silvia Scelsi

This work is licensed under a Creative Commons Attribution 4.0 International License.
Abstract
Introduction. Adaptation to extrauterine life is challenging for preterm babies. Environmental stimuli, like noises, could lead to adverse health outcomes, causing instability in vital parameters and neurodevelopment impairment. American Academy of Pediatrics recommends a maximum environmental noise ≤ 45 decibels (dB) in the Newborn Intensive Care Units (NICUs). We hypothesise that listening to white noises and parental voices could mitigate the adverse outcomes caused by noises > 45 dB on preterm babies.
Methods. A randomised controlled trial (ClinicalTrials.gov, NCT06150404) aimed to include preterm babies of ≥31 weeks gestation, meeting the specific inclusion criteria. Data regarding environmental noises and vital parameters will be collected from all patients enrolled from the day of enrollment till their discharge. In addition, data regarding language and hearing development will be collected respectively after three years and three months from discharge. A soundtrack with white noises and parental voices will be administered to preterm babies enrolled in the intervention group through an mp3 device.
Expected Results. If our hypothesis is confirmed, this study could benefit preterm babies by reducing adverse outcomes linked to excessive environmental noise, such as vital parameters instability and language and hearing impairment. Study results could also affect care practices in NICU settings to ensure patient safety, even if the null hypothesis is confirmed. The data collected will be utilised to understand environmental noise levels in our NICU and implement improvement projects in their management.
References
- World Health Organization. Born Too Soon: Decade of Action on Preterm Birth. Geneva: WHO; 2023. Licence: CC BY-NC-SA 3.0 IGO. https://creativecommons.org/licenses/by-nc-sa/3.0/igo/
- Altimier L, Phillips RM. The neonatal integrative developmental care model: seven neuroprotective core measures for family-centered developmental care. Newborn Infant Nurs Rev. 2013;13:9–22. doi:10.1053/j.nainr.2012.12.002
- VandenBerg KA. Individualised developmental care for high-risk newborns in the NICU: a practice guideline. Early Hum Dev. 2007;83:433–442. doi:10.1016/j.earlhumdev.2007.03.008
- Liao JH, et al. The noise and light level in the neonatal intensive care unit. J Nurs Sci. 2018;33:11–13. doi:10.3870/j.issn.1001-4152.2018.08.021
- Garrido Galindo AP, Camargo Caicedo Y, Velez-Pereira AM. Noise level in intensive care units of a public university hospital in Santa Marta (Colombia). Med Intensiva. 2016;40(7):403–410. doi:10.1016/j.medin.2015.11.01
- American Academy of Pediatrics. Noise: a hazard for the fetus and newborn. Pediatrics. 1997;100:724–727. doi:10.1542/peds.100.4.724
- Andy L, Fan H, Valerie S, Jing W. Systematic review of environmental noise in neonatal intensive care units. Acta Paediatr. 2025;114(1):35–50. doi:10.1111/apa.17445
- Fernández Zacarías F, Beira Jiménez JL, Bustillo Velázquez-Gaztelu PJ, et al. Noise level in neonatal incubators: a comparative study of three models. Int J Pediatr Otorhinolaryngol. 2018;107:150–154. doi:10.1016/j.ijporl.2018.02.013
- Falk S. Noise pollution; neonatal aspects. Pediatrics. 1974;54:1–3.
- Wachman EM, Lahav A. The effects of noise on preterm infants in the NICU. Arch Dis Child Fetal Neonatal Ed. 2011;96(4):F305–F309. doi:10.1136/adc.2009.182014
- Shellhaas RA, Burns JW, Barks JDE, et al. Maternal voice and infant sleep in the neonatal intensive care unit. Pediatrics. 2019;144:e20190288. doi:10.1542/peds.2019-0288
- National Health System. Guideline for Consideration of Noise on the Neonatal Unit. 2019:1–13.
- Zimmerman E, Lahav A. Ototoxicity in preterm infants: effects of genetics, aminoglycosides, and loud environmental noise. J Perinatol. 2013;33:3–8. doi:10.1038/jp.2012.105
- Monson BB, Rock J, Cull M, Soloveychik V. Neonatal intensive care unit incubators reduce language and noise levels more than the womb. J Perinatol. 2020;40:600–606. doi:10.1038/s41372-020-0592-6
- Jobe AH. A risk of sensory deprivation in the neonatal intensive care unit. J Pediatr. 2014;164:1265–1267.
- Monson BB, Rock J, Cull M, Soloveychik V. Neonatal intensive care unit incubators reduce language and noise levels more than the womb. J Perinatol. 2020;40:600–606. doi:10.1038/s41372-020-0592-6
- Ahamed MF, Campbell D, Horan S, Rosen O. Noise reduction in the neonatal intensive care unit: a quality improvement initiative. Am J Med Qual. 2018;33:177–184. doi:10.1177/1062860617711563
- Wang D, et al. Examining the effects of a targeted noise reduction program in a neonatal intensive care unit. Arch Dis Child Fetal Neonatal Ed. 2014;99:F203–F209. doi:10.1136/archdischild-2013-304928
- Calikusu Incekar M, Balci S. The effect of training on noise reduction in neonatal intensive care units. J Spec Pediatr Nurs. 2017;22:e12181. doi:10.1111/jspn.12181
- Pineda R, Durant P, Mathur A, et al. Auditory exposure in the neonatal intensive care unit: room type and other predictors. J Pediatr. 2017;183:56–66.e3.
- Smith SW, Ortmann AJ, Clark WW. Noise in the neonatal intensive care unit: a new approach to examining acoustic events. Noise Health. 2018;20:121–130. doi:10.4103/nah.NAH_53_17
- Hernández-Salazar AD, Gallegos-Martínez J, Reyes-Hernández J. Level and noise sources in the neonatal intensive care unit of a reference hospital. Invest Educ Enferm. 2020;38(3):e13. doi:10.17533/udea.iee.v38n3e13
- Parra J, de Suremain A, Audeoud F, et al. Sound levels in a neonatal intensive care unit significantly exceeded recommendations, especially inside incubators. Acta Paediatr. 2017;106:1909–1914. doi:10.1111/ijlh.12426
- Sibrecht G, Wróblewska-Seniuk K, Bruschettini M. Noise or sound management in the neonatal intensive care unit for preterm or very low birth weight infants. Cochrane Database Syst Rev. 2024;5:CD010333. doi:10.1002/14651858.CD010333.pub4
- Suna Dağ Y, Yayan EH. The effect of facilitated tucking and white noise on stress and sleep of newborns receiving nasal continuous positive airway pressure. J Pediatr Nurs. 2024;77:e442–e449. doi:10.1016/j.pedn.2024.05.008
- Spencer JAD, Moran DJ, Lee A, Talbert D. White noise and sleep induction. Arch Dis Child. 1990;65:135–137. doi:10.1136/adc.65.1.135
- Forquer LAM, Johnson CM. Continuous white noise to reduce resistance going to sleep and night wakings in toddlers. Child Fam Behav Ther. 2005;27:1–10. doi:10.1300/J019v27n02_01
- Düken ME, Yayan EH. The effects of massage therapy and white noise application on premature infants’ sleep. Explore (NY). 2024;20(3):319–327. doi:10.1016/j.explore.2023.09.002
- Zhang Q, Huo Q, Chen P, et al. Effects of white noise on preterm infants in the neonatal intensive care unit: a meta-analysis of randomised controlled trials. Nurs Open. 2024;11(1):e2094. doi:10.1002/nop2.2094
- Kim MH, Song JE, Ahn JA, You MA. Effect of white noise on pain response, heart rate, and oxygen saturation during heel puncture in premature infants: a randomized controlled trial. J Perinat Neonatal Nurs. 2024;38(3):297–305. doi:10.1097/JPN.0000000000000779
- Filippa M, et al. Systematic review of maternal voice interventions demonstrates increased stability in preterm infants. Acta Paediatr. 2017;106:1220–1229. doi:10.1111/ijlh.12426
- Qi M, Gong J, Xie Z, et al. Effects of recorded maternal voice on anthropometric parameters and heart rate in premature infants: a pilot randomised controlled trial. J Pediatr Nurs. 2023;72:e122–e129. doi:10.1016/j.pedn.2023.06.018
- Filippa M, Filippa G, Della Casa E, et al. Maternal singing and speech have beneficial effects on preterm infant’s general movements at term equivalent age and at 3 months: an RCT. Front Psychol. 2025;16:1536646. doi:10.3389/fpsyg.2025.1536646
- Caskey M, Stephens B, Tucker R, Vohr B. Importance of parent talk on the development of preterm infant vocalisations. Pediatrics. 2011;128(5):910–916. doi:10.1542/peds.2011-0609
- Chan AW, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.
- Altman DG. CONSORT 2010 Guideline. 2010.
- Cundill B, Alexander ND. Sample size calculations for skewed distributions. BMC Med Res Methodol. 2015;15:28. doi:10.1186/s12874-015-0023-0
- Lary S, Briassoulis G, de Vries L, Dubowitz LM, Dubowitz V. Hearing threshold in preterm and term infants by auditory brainstem response. J Pediatr. 1985;107(4):593–599. doi:10.1016/s0022-3476(85)80030-5
- Williams AL, Sanderson M, Lai D, et al. Intensive care noise and mean arterial blood pressure in extremely low-birth-weight neonates. Am J Perinatol. 2009;26:323–329. doi:10.1055/s-0028-1104741
- Cardoso SMS, Kozlowski LC, de Lacerda ABM, et al. Newborn physiological responses to noise in the neonatal unit. Braz J Otorhinolaryngol. 2015;81:583–588. doi:10.1016/j.bjorl.2014.11.008
- Detmer MR, Whelan ML. Music in the NICU: the role of nurses in neuroprotection. Neonatal Netw. 2017;36:213–217. doi:10.1891/0730-0832.36.4.213