Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-28 @ 6:50 AM
Study NCT ID:
NCT06150404
Status:
TERMINATED
Last Update Posted:
2025-01-21
First Post:
2023-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Istituto Giannina Gaslini
Organization:
Study Overview
Official Title:
Parents' Voice and White Noises in Neonatal Intensive Care Unit: Efficacy Evaluation Against Noises' Damage - a Randomized Controlled Trial
Status:
TERMINATED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
From the preliminary data analysis, some unexpected results emerged that conducted us to terminate the enrollment.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: