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

Istituto Giannina Gaslini

Status

Terminated

Conditions

Premature Infant Disease

Treatments

Behavioral: White Noises and Maternal and/or Paternal voices

Study type

Interventional

Funder types

Other

Identifiers

NCT06150404

SR-WHTNSS1

Details and patient eligibility

About

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.

Enrollment

11 patients

Sex

All

Ages

31+ weeks old

Volunteers

No Healthy Volunteers

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.