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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

NCT06150404 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-01-21

No results posted yet for this study

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.

Conditions

  • Premature Infant Disease

Interventions

BEHAVIORAL

White Noises and Maternal and/or Paternal voices

The intervention group will receive white noise and maternal and/or paternal voice for a maximum of 4 hours per day, alternated as follows: 1 hour and 30 minutes of white noise, 30 minutes of maternal and/or paternal voice, 1-hour break, 1 hour and 30 minutes of white noise, 30 minutes of maternal and/or paternal voice. The intervention is expected to start at 08:00 in the morning and conclude at 13:00 and will be delivered from the day after the enrollment - when the parents provide their voice recording - until the day of discharge. The device for administering white noise and maternal and/or paternal voice will be placed approximately 30 cm from the head of the infant in the incubator and at the foot of the infant in the open crib. The volume will be 45 dB for infants in incubators and infants in open cribs.

Sponsors & Collaborators

  • Eubrain

    collaborator UNKNOWN

  • Istituto Giannina Gaslini

    lead OTHER

Principal Investigators

  • Simona Serveli, RN · Department of Health Profession, IRCCS Istituto Giannina Gaslini

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
31 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06150404 on ClinicalTrials.gov