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

March 5, 2024 updated by: Silvia Rossi, Istituto Giannina Gaslini

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Genova, Italy, 16145
        • Recruiting
        • IRCCS Istituto Giannina Gaslini
        • Contact:
        • Sub-Investigator:
          • Ilaria Artuso, BSN
        • Principal Investigator:
          • Silvia Rossi, PhD
        • Sub-Investigator:
          • Giulia Ottonello, BSN
        • Sub-Investigator:
          • Simona Serveli, RN
        • Sub-Investigator:
          • Annalisa Vittoria, RN
        • Sub-Investigator:
          • Vanessa Ferreri, RN
        • Sub-Investigator:
          • Denise Ruaro, RN
        • Sub-Investigator:
          • Serena Furnari, RN
        • Sub-Investigator:
          • Martina Parisi, RN
        • Sub-Investigator:
          • Stefano Parodi, Statistician
        • Sub-Investigator:
          • Laura Scatimburgo, Psycologyst

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients admitted to the NICU with gestational age at birth ≥ 31 weeks (as this is the age at which sound perception is ≥ 40 dB and there is predictable clinical stability to allow intervention delivery without excessive interruptions)
  • Patients admitted to the NICU who reach gestational age ≥ 31 weeks
  • Patients monitored with the following types of monitors: Masimo rainbow SET™ (Masimo); Infinity® Delta (Draeger); Infinity® Acute Care System (Draeger); Efficia CM (Philips).

Exclusion Criteria:

  • Patients with gestational age at birth < 31 weeks
  • Patients affected by meningitis or severe cerebral insults, congenital brain anomalies, congenital syndromes with suspected or known brain dysfunction
  • Patients diagnosed with hypoxic-ischemic encephalopathy
  • Patients with significant airway abnormalities resulting in altered breathing during sleep
  • Patients with terminal illnesses
  • Patients with congenital anomalies of the face, ears, skull, or brain
  • Patients with non-bacterial congenital infections
  • Patients with congenital hearing deficits
  • Patients whose parents or legal guardians refuse to participate in the study
  • Patients already enrolled in other clinical studies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Those in the intervention group will receive the administration of white noises and maternal and/or paternal voice recording.
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.
No Intervention: Control Group
Those enrolled in the control group will receive standard care and will be subjected to the usual level of ambient noise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of heart rate alteration
Time Frame: Through study completion, an average of 2 year
Reduction, in the patients enrolled in the intervention group compared to the control group, in episodes of heart rate alteration associated with noises > 45 dB (nursing diagnosis: risk of tachycardia - HR >180 bpm - correlated with environmental exposure to noises > 45dB).
Through study completion, an average of 2 year
Reduction of oxygen saturation alteration
Time Frame: Through study completion, an average of 2 year
Reduction, in the patients enrolled in the intervention group compared to the control group, in episodes of oxygen saturation alteration associated with noises > 45 dB (nursing diagnosis: risk of desaturation - SpO2 <90% - correlated with environmental exposure to noises > 45dB).
Through study completion, an average of 2 year
Reduction of respiratory rate alteration
Time Frame: Through study completion, an average of 2 year
Reduction, in the patients enrolled in the intervention group compared to the control group, in episodes of respiratory rate alteration associated with noises > 45 dB (nursing diagnosis: risk of tachypnoea - RR >60 breaths per minute - correlated with environmental exposure to noises > 45dB).
Through study completion, an average of 2 year
Reduction of episodes of apnoea
Time Frame: Through study completion, an average of 2 year
Reduction, in the patients enrolled in the intervention group compared to the control group, in episodes of apnoea associated with noises > 45 dB (nursing diagnosis: risk of apnoea - HR <100 bpm and SpO2 <90% - correlated with environmental exposure to noises > 45dB).
Through study completion, an average of 2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in Language Development Alterations
Time Frame: From enrollment unitl 3 years of age
The study will assess whether there is a reduction in language development issues in the intervention group compared to the control group. This evaluation will be conducted during a follow-up assessment at 3 years of age. The nursing diagnosis being considered is "risk of impaired verbal communication related to hospitalization in the NICU."
From enrollment unitl 3 years of age
Reduction in Hearing Development Alterations
Time Frame: From enrollment unitl 3 months of age
The study will also assess whether there is a reduction in hearing development issues in the intervention group compared to the control group. These evaluations will be conducted at a follow-up assessment at 3 months of age and any subsequent audiometric examinations. The nursing diagnosis being considered is "risk of compromised hearing development related to hospitalization in the NICU."
From enrollment unitl 3 months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Giannina Gaslini

Collaborators

Eubrain

Investigators

  • Study Chair: Simona Serveli, RN, Department of Health Profession, IRCCS Istituto Giannina Gaslini

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

November 13, 2023

First Submitted That Met QC Criteria

November 20, 2023

First Posted (Actual)

November 29, 2023

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SR-WHTNSS1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data could be shared under a motivated request, only anonymised and grouped in databases.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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