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 @ 2:56 AM
Ignite Modification Date:
2025-12-25 @ 2:56 AM
NCT ID:
NCT05391633
Eligibility Criteria:
Inclusion Criteria:
* Infants born at 28 0/7 - 32 3/7 weeks gestation (to allow for infants born at 32 3/7 weeks to have initial EEG performed after 72 hours of life and prior to initiating intervention or non-intervention arm at 33 0/7 weeks gestation)
* Mother available to provide voice recording, and have ability to converse and read in English (as the scripted content for the intervention will be provided in English)
Exclusion Criteria:
* Infant with Critical Congenital Cardiac Disease
* Infant with Chromosomal anomaly or Inborn Error of Metabolism
* Infant with known Neurologic disorder/abnormality - including hypoxic-ischemic encephalopathy (HIE), intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), seizure activity, anatomic abnormality
* Infant receiving antiepileptic or sedation medications prior to EEG
* Initial EEG abnormal with epileptiform activity or not consistent with corrected gestational age
* Mother not available to provide voice recording in English
* Unable to obtain consent from mother due to maternal health issues following delivery (such as mother requiring intubation or sedation following delivery
* Mothers who are prisoners (as the study team would like to have continuing communication during the study period as needed)
* Mothers who are \<18 years of age will not be approached for consent
* Any mother that is not able to consent due to having a legal representative will not be approached for consent
* Any infant that is planned to be placed for adoption, is in foster care or is a ward of the state
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
28 Weeks
Maximum Age:
33 Weeks
Study:
NCT05391633
Study Brief:
Protocol Section:
NCT05391633