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

Study Overview
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Brief Summary
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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.

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

Conditions
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Premature Infant Disease

Intervention / Treatment
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* Behavioral: White Noises and Maternal and/or Paternal voices


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 31 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participation in intervention or control groups will occur using simple randomization techniques. Randomization will be achieved by creating a randomization list using specialized software. The randomization algorithm will be protected. The allocation sequence will be done using sealed opaque envelopes (making it impossible to read the contents), each numbered sequentially, containing the indication of assignment to the intervention group or the control group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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<br>* 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.<br>|
| No Intervention: Control Group<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of heart rate alteration | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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premature, nursing care, randomized controlled trial, developmental care, noises damage, Newborn intensive care unit, white noises, parental voices