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 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT04214834
Eligibility Criteria:
Inclusion Criteria:
* Hospital Level
1. Hospital provides pharmacologic treatment to at least an average of 12 opioid exposed infants each year
2. Hospital uses a scoring system to assess for signs of NOWS (original or modified Finnegan Neonatal Abstinence Scoring system, Eat-Sleep or Console)
3. Hospital provides opioid replacement therapy with either morphine or methadone as part of pharmacologic treatment of NOWS
* Infant Level
1. Gestational age ≥ 36 weeks
2. Receiving scheduled pharmacological therapy with morphine or methadone as the primary drug treatment for NOWS secondary to maternal opioid use
3. Tolerating enteral feeds and medications by mouth
Exclusion Criteria:
* Hospital Level
1\. Hospitals discharge \> 10% of infants from the hospital on opioid replacement therapy on average per year
* Infant Level
1. Major birth defect (e.g. gastroschisis)
2. Any major surgery (minor surgery \[e.g., circumcision, digit ligation, frenulectomy\] is not an exclusion criterion)
3. Hypoxic-ischemic encephalopathy
4. Seizures from etiologies other than NOWS
5. Treatment with opioids for reasons other than NOWS
6. Respiratory support (nasal cannula or greater) for \> 72 hours
7. Planned discharge from the hospital on opioids
8. Use of other opioids (e.g., buprenorphine) as primary drugs for treatment of NOWS
9. Weaning of morphine or methadone as the primary treatment of NOWS has started
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
36 Weeks
Study:
NCT04214834
Study Brief:
Protocol Section:
NCT04214834