Status:
TERMINATED
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
Lead Sponsor:
Istituto Giannina Gaslini
Collaborating Sponsors:
Eubrain
Conditions:
Premature Infant Disease
Eligibility:
All Genders
31+ years
Phase:
NA
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 Int...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT06150404
Start Date
February 1 2024
End Date
December 31 2024
Last Update
January 21 2025
Active Locations (1)
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1
IRCCS Istituto Giannina Gaslini
Genova, Genova, Italy, 16145