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 @ 4:46 AM
Ignite Modification Date:
2025-12-25 @ 4:46 AM
NCT ID:
NCT04531618
Eligibility Criteria:
Inclusion Criteria:
* Mother agrees to participate in a linked study involving additional surveys and assessments
* Newborn born between 35 weeks and 40 weeks and 6 days gestational age
* Newborn is a singleton
* Mother can speak English or Spanish
Exclusion Criteria:
* Newborn born at less than 35 weeks and 0 days gestational age
* Newborn born at more than 40 weeks and 6 days gestational age
* Infant's attending physician does not recommend enrollment in the study based on newborn health concerns or diagnoses, or based on concern regarding maternal history of maternal substance abuse, severe psychiatric illness or psychosis
* Mother and/or infant has a medical condition that precludes intervention components
* Newborn is a twin or other multiple at birth
* Mother is unwilling to be video recorded
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Hours
Maximum Age:
72 Hours
Study:
NCT04531618
Study Brief:
Protocol Section:
NCT04531618