Clinical trial NCT06150404: 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
Official title: Parents' Voice and White Noises in Neonatal Intensive Care Unit: Efficacy Evaluation Against Noises' Damage - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Premature Infant Disease
Keywords: premature
nursing care
randomized controlled trial
developmental care
noises damage
Newborn intensive care unit
white noises
parental voices
Lead sponsor: Istituto Giannina Gaslini
Sponsor class: OTHER
Collaborators: name: Eubrain
First posted: 2023-11-29
Enrollment: 11
Sex: ALL
Minimum age (years): 31
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Reduction of heart rate alteration
timeFrame: Through study completion, an average of 2 year
measure: Reduction of oxygen saturation alteration
timeFrame: Through study completion, an average of 2 year
measure: Reduction of respiratory rate alteration
timeFrame: Through study completion, an average of 2 year
measure: Reduction of episodes of apnoea
timeFrame: Through study completion, an average of 2 year
Secondary outcomes:
measure: Reduction in Language Development Alterations
timeFrame: From enrollment unitl 3 years of age
measure: Reduction in Hearing Development Alterations
timeFrame: From enrollment unitl 3 months of age
Other outcomes:
Locations:
city: Genova
country: Italy
facility: IRCCS Istituto Giannina Gaslini
Study officials:
affiliation: Department of Health Profession, IRCCS Istituto Giannina Gaslini
name: Simona Serveli, RN
role: STUDY_CHAIR
References: