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 @ 2:31 AM
Ignite Modification Date:
2025-12-25 @ 2:31 AM
NCT ID:
NCT06839534
Eligibility Criteria:
Inclusion Criteria:
1. Preterm infants born at 32-36 weeks gestational age
2. Receiving care in the Neonatal Intensive Care Unit (NICU) at QSNICH
3. Stable vital signs with no severe medical complications that would interfere with auditory perception
4. Mothers willing and able to provide pre-recorded voice messages for SMVP
5. Parental informed consent obtained
Exclusion Criteria:
1. Critically unstable infants with severe medical complications (e.g., respiratory failure, severe metabolic acidosis)
2. Infants with diagnosed auditory or neurological impairments affecting response to maternal voice
3. Infants with severe intraventricular hemorrhage (Grade III or higher)
4. Mothers unable to provide pre-recorded voice messages due to health or psychological limitations
5. Families declining participation or withdrawing consent
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
36 Weeks
Study:
NCT06839534
Study Brief:
Protocol Section:
NCT06839534