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 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT05980260
Eligibility Criteria:
Inclusion Criteria:
1. The infant is greater than or equal to 36 weeks gestation.
2. The infant had antenatal opioid exposure identified by at least one of the following:
* History of maternal opioid use during pregnancy;
* Positive maternal toxicology screen for opioids during the second or third trimester of pregnancy; and/or
* Positive infant toxicology screen for opioids during the initial hospital stay.
3. The infant is being assessed and managed for NOWS at an eligible study site.
4. The infant is at risk for pharmacologic treatment for NOWS defined by either of the following
* At least 1 score ≥ 8 if assessed and managed with FNAST or modification thereof
* At least 1 "yes" if assessed and managed with the ESC care approach
Exclusion Criteria:
1. The infant has major birth defect(s).
2. The infant has neonatal encephalopathy (inclusive of hypoxic ischemic encephalopathy), a metabolic disorder, stroke, intracranial hemorrhage, or meningitis diagnosed prior to the initiation of pharmacologic treatment.
3. The infant is receiving respiratory support (any positive pressure or oxygen therapy) at 48 hours of age.
4. The infant has undergone major surgical intervention prior to or at 48 hours of age.
5. The infant has postnatal opioid exposure prior to the initiation of treatment for NOWS.
6. The infant was outborn and pharmacologic treatment was initiated at the transferring hospital.
7. The infant is assessed for eligibility during the study site's three-week washout period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Hour
Maximum Age:
48 Hours
Study:
NCT05980260
Study Brief:
Protocol Section:
NCT05980260