Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT06150404
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
31 Weeks
Study:
NCT06150404
Study Brief:
Protocol Section:
NCT06150404