White Noises and Parental Voices Against Noises Damage in Preterm Babies: a Randomised Trial’s Protocol

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.