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:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT01427894
Eligibility Criteria:
Inclusion criteria clinically stable infants
* postmenstrual age \<37 weeks
* normal hearing confirmed by measurement of distortion product otoacoustic emission (DPOAE).
Exclusion criteria
* observed hyperresponsiveness to live music
* congenital anomaly that mainly affects hearing
* medication intake (phenobarbital, furosemide, gentamycin) that might interfere with the reaction to musical stimuli
* brain anomalies associated with neurological disorders (grade 3-4 intraventricular hemorrhage, periventricular leukomalacia).
Maternal inclusion criteria
* ability to hear
* literary ability to read and answer an anxiety questionnaire
Maternal exclusion criteria
* signs or medical history of postpartum depression
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Week
Maximum Age:
6 Months
Study:
NCT01427894
Study Brief:
Protocol Section:
NCT01427894