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:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-26 @ 4:03 PM
NCT ID:
NCT07295106
Eligibility Criteria:
Inclusion Criteria:
* Preterm infants admitted to the Neonatal Intensive Care Unit (NICU) of Azienda Ospedaliera di Perugia, Santa Maria della Misericordia, Perugia (Italy) at the time of enrollment.
* Gestational age at birth 28+0 to 36+6 weeks.
* Age at enrollment: 5 to 15 days.
* Stable vital signs at enrollment per unit policy.
* Apgar score at 5 minutes ≥ 7.
* Birth weight appropriate for gestational age, between the 50th and 90th percentile.
* Written informed consent from parent(s) or legal guardian(s).
Exclusion Criteria:
* Post-operative status at the time of enrollment.
* One or more of the following: intraventricular hemorrhage, necrotizing enterocolitis, sepsis, significant pulmonary disease, or neonatal anemia.
* Congenital anomalies.
* Hypersensitivity or intolerance to sound.
* Maternal history of drug and/or alcohol misuse during pregnancy.
* Lack of parental consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Days
Maximum Age:
15 Days
Study:
NCT07295106
Study Brief:
Protocol Section:
NCT07295106