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:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT03567603
Eligibility Criteria:
Inclusion Criteria:
* Gestational age ≥ 36 weeks, confirmation of dates via ultrasound or last menstrual period
* Prenatal opioid exposure ("exposed"), confirmed via admitted use or newborn drug screen; no prenatal opioid exposure ("control") by maternal report or testing
* All races, ethnicities, sexes to be included
* Informed permission form signed by mother
Exclusion Criteria:
* Birth weight ≤ 3rd percentile or ≥ 97th percentile for gestational age
* Have comorbid medical disorders including; those associated with sensorineural hearing loss, significant congenital anomalies, congenital heart disease, known brain injury/malformations
* Infants requiring mechanical ventilation
* Infants requiring continuous sedation
Sex:
ALL
Maximum Age:
20 Days
Study:
NCT03567603
Study Brief:
Protocol Section:
NCT03567603