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A Randomized Controlled Trial to Evaluate the Effect of White Noises and Parental Voices as Protectors Against Noise Damage in a Neonatal Intensive Care Unit

Premature Infant Disease Clinical Trial

Official title:
Parents' Voice and White Noises in Neonatal Intensive Care Unit: Efficacy Evaluation Against Noises' Damage - a Randomized Controlled Trial

Clinical Trial Summary

The goal of this Randomized Controlled Trial is to test the efficacy of listening to white noises and parental voices against environmental noise damage in premature babies admitted to the Newborn Intensive Care Unit. The main question it aims to answer is: • Could the combined use of white noises and maternal and/or paternal voices reduce the negative outcomes of continuous exposure to hospital noises on newborns hospitalized in a Neonatal Intensive Care Unit? Participants in the intervention group will listen to a recorded track composed of white noises and voices of their parents who read a story or sing a lullaby from the day of enrollment until the day of discharge, for 4 hours per day. Researchers will compare the intervention group with the control group (who will receive the usual care provided without any intervention on the noise level) to see if babies enrolled in the intervention group show fewer events of tachycardia, tachypnea, desaturation, apnoea, and language or hearing impairment.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06150404
Study type Interventional
Source Istituto Giannina Gaslini
Contact Silvia Rossi, PhD
Phone 0039 3484929066
Email silviarossi@gaslini.org
Status Recruiting
Phase N/A
Start date February 1, 2024
Completion date December 2027
View Details
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