Stopped: From the preliminary data analysis, some unexpected results emerged that conducted us to terminate the enrollment.
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.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Reduction of heart rate alteration
Timeframe: Through study completion, an average of 2 year
Reduction of oxygen saturation alteration
Timeframe: Through study completion, an average of 2 year
Reduction of respiratory rate alteration
Timeframe: Through study completion, an average of 2 year
Reduction of episodes of apnoea
Timeframe: Through study completion, an average of 2 year